Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notes supplémentaires dans les données
Medical Device Safety Alert
Cause
Medical device safety alert: abbott alinity i processing module
medical device manufacturer, abbott, has issued a medical device safety alert concerning its alinity i processing module [list number: 03r65, serial numbers: ai01001 to ai01336].
the manufacturer has identified an issue with the alinity i bulk solution dispense pumps (part number a‐35001280‐01) resulting in pump failures. the issue is linked to the design of an internal seal within the pump that allows a small amount of leakage of bulk solution. the failure of the pump could result in unexpected instrument down time potentially causing a delay in generating results.
according to the manufacturer, the amount of the leakage does not impact the ability of the pump to accurately dispense bulk solutions, and the leakage is contained within the service‐only area of the instrument. therefore, the issue does not pose a risk of incorrect results nor a risk of physical exposure to the operator.
according to the local supplier, the affected products are distributed in hong kong.
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 21 sep 2018.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notes supplémentaires dans les données
Medical Device Safety Alert
Cause
Medical device safety alert: richard wolf gmbh texas bronchoscope tube
medical device manufacturer, richard wolf gmbh, has issued a medical device safety alert concerning its texas bronchoscope tube [product numbers: 825200641, 825200841, 825200842, 825201041, 825201241, 825201441, 825210830, 825211230, and 825211430].
the manufacturer became aware of a potential deficiency of its texas bronchoscope tube product. non-functionally relevant bonding points / cemented areas of the affected products may come loose and therefore lead to an extension of the operating time.
generally the affected user discovers such separations of fibers of glue during the visible and the function inspection. they are advised to check their stock and return the affected products to the manufacturer for device correction.
according to the manufacturer, the affected products are distributed in hong kong.
if you are in possession of the products, please contact your supplier for necessary actions.
posted on 21 september 2018.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notes supplémentaires dans les données
Medical Device Safety Alert
Cause
Medical device safety alert: coopersurgical single-use cpo-6 colpo-pneumo occluder
medical device manufacturer, coopersurgical, has issued a medical device safety alert concerning its single-use cpo-6 colpo-pneumo occluder [part number: cpo-6; lot numbers: 244131, 244132, 244670, 244671, 244887, 244888, 244889, 244890, 245228, 245325, 245326, 245327, 245613, 245614, 245615, 245976, 245977, 245978, 245979, 246810, 246811, 247262, 247608, 247609, 247610, & 248112]
the manufacturer is recalling 26 lots of the affected product due to the possibility that the seal of the sterile pouch may be compromised, thereby increasing the risk of infection. this condition was detected during a complaint investigation unrelated to the packaging seal. there have not been any adverse events reported to coopersurgical due to this potential issue.
the manufacturer has initiated a corrective action to inspect finished goods in inventory for potential unsealed pouches.
according to the manufacturer, a product is acceptable for use if it is visually confirmed that the pouch’s seal is intact. as indicated in the directions for use, each package should be handled with care and inspected for damage, including the seal area before use.
the affected users are advised to inspect the package contents and the sterile seal along the entire periphery of the package. they should discontinue use of the product with any packaging irregularities and quarantine the product,
product replacement is on-going.
according to the manufacturer, the affected products are distributed in hong kong.
if you are in possession of the products, please contact your supplier for necessary actions.
posted on 14 september 2018.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notes supplémentaires dans les données
Medical Device Safety Alert
Cause
Medical device safety alert: boston scientific latitude programmer model 3300
medical device manufacturer, boston scientific, has issued a medical device safety alert concerning its latitude programmer [model: 3300; description: prgmr latitude us 3300].
upon limited market release to the us in may 2018, customer complaints were received regarding the 3300 programmer integrated pacing system analyzer (psa) when attempting to evaluate lead impedances. complaints described that while pacing the ra lead, capture and pacing were also observed in the rv lead.
according to the manufacturer, the pir team concludes that while the product is manufactured per specifications, the current cross chamber stimulation behaviour does not meet the intent of system requirements. therefore, the psa application reflects an increase risk to patients and a field removal is recommended to return 3300 programmers to the manufacturer.
the 3300 is also in limited market release in europe. no other geographies are currently approved for the 3300-programmer use.
according to the local supplier, the affected products are not distributed in hong kong.
if you are in possession of the products, please contact your supplier for necessary actions.
posted on 13 september 2018.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notes supplémentaires dans les données
Medical Device Safety Alert
Cause
Medical device safety alert: medtronic o-arm 1000 imaging systems
medical device manufacturer, medtronic, has issued a medical device safety alert concerning all 2nd edition o-arm 1000 imaging system. the affected devices are identified as follow:
product names (catalogue number)
oarm assy bi70000027 system product (bi70000027)
oarm assy bi70000027r sys product rwk (bi70000027r)
base oarm bi70000027100 system 100v (bi70000027100)
base oarm bi70000027100r system 100v rwk (bi70000027100r)
base oarm bi70000027120 system 120v (bi70000027120)
base oarm bi70000027120r system 120v rwk (bi70000027120r)
base oarm bi70000027230 system 230v (bi70000027230)
base oarm bi70000027230r system 230v rwk (bi70000027230r)
oarm assy bi70000027ger sys product ger (bi70000027ger)
oarm assy bi70000027gerr sys product refurb (bi70000027gerr)
the manufacturer released software version 3.1.7. the change is in response to customer complaints and addresses several known software anomalies. the software anomalies were reported to affect the following system functionalities:
startup and shutdown
system and network communication
motion control
image acquisition and output
dose reporting
logs generation
according to the manufacturer, over the last six years, five complaints led to cancelled procedures after the patient was under anaesthesia requiring additional surgery. the field action is being initiated to address the issues relating to these complaints.
the local supplier will contact affected users to schedule completion of the software install. the affected users may choose to continue to use their 2nd edition o-arm 1000 imaging system at their clinical discretion in the meantime, but they should be aware of the issues described above, which may result in a delayed surgery, patient exposure to non-navigated surgery, patient exposure to additional surgery or unused x-ray dose.
according to the local supplier, the affected products are distributed in hong kong.
if you are in possession of the products, please contact your supplier for necessary actions.
posted on 10 september 2018.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notes supplémentaires dans les données
Medical Device Safety Alert
Cause
Medical device safety alert: abbott alere nt-probnp for architect controls
medical device manufacturer, abbott laboratories, has issued a medical device safety alert concerning its alere nt-probnp for architect controls. the affected devices are identified as follow:
list number: 2r10-10;
lot number: a) 902917627; b) 902918346
expiration date: a) 19 december 2018; b) 16 february 2019
udi number:
a) (01)05055845400404(17)181219(10)902917627;
b) (01)05055845400404(17)190216(10)902918346
abbot laboratories becomes aware that the manufacturer of the alere nt-probnp for architect controls, axis-shield, has identified a stability issue that may lead to quality control values falling outside of expected ranges prior to assigned expiry date.
according to the manufacturer, a potential delay may exist in the reporting of patient results due to quality control values falling outside of expected ranges. internal testing on patient samples showed no atypical bias for the impacted lots, therefore if quality controls are in range, patient results are not impacted.
if affected users have an alternate control lot available in inventory, they should immediately discontinue use of the affected control lot(s) and switch to the alternate control lot. they should also destroy any remaining inventory of impacted material according to their laboratory procedures.
if the affected users do not have an alternate control lot available in inventory and the current lot continues to generate valid qc results, they should immediately order a replacement control lot. they may continue to use the affected control lot(s) while following their current laboratory qc procedures. once they receive the replacement control lot, they may destroy any remaining inventory of impacted material according to their laboratory procedures.
product replacement is on-going.
according to the local supplier, the affected products are distributed in hong kong.
if you are in possession of the products, please contact your supplier for necessary actions.
posted on 4 september 2018.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notes supplémentaires dans les données
Medical Device Safety Alert
Cause
Medical device safety alert: abbott architect ict module
medical device manufacturer, abbott laboratory, has issued a medical device safety alert concerning its architect ict module. the affected devices are identified as follow:
list number: 09d28-03;
lot number: 180326;
expiration date: 26 december 2018;
udi: (01)00380740019327(17)181226(10)180326(21)180326301 through (01)00380740019327(17)181226(10)180326(21)180326399.
the manufacturer has received customer complaints regarding higher than expected serum or plasma chloride results when using the affected products. based on an analysis of quality control (qc) data from existing customers, the results generated using this lot number may be up to 6.2% higher than expected. the customer qc data do not indicate an issue with urine chloride results.
according to the manufacturer, the issue only impacts the chloride electrode element of the ict module, potassium and sodium results are not impacted. there is the potential to generate falsely elevated serum or plasma chloride results when using the affected products. there is also the potential to delay the reporting of chloride ict results due to the time required for the user to attempt troubleshooting of the issue with falsely elevated serum chloride qc results.
the affected users are advised to immediately discontinue the use of the affected products. they should destroy any remaining inventory of the impacted lot number according to their laboratory procedures. they also should discuss with their medical director and follow their laboratory protocol regarding the need for reviewing previously reported patient results.
product replacement is on-going.
according to the local supplier, the affected products are distributed in hong kong.
if you are in possession of the products, please contact your supplier for necessary actions.
posted on 4 september 2018.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notes supplémentaires dans les données
Medical Device Safety Alert
Cause
Medical device safety alert: medtronic heartware hvad system controller/ controller kits
medical device manufacturer, heartware (a part of medtronic), has issued a medical device safety alert concerning its heartware hvad system controller/ controller kits [model numbers: 1403, 1407, 1420; serial number range: con300175 – con320540].
the manufacturer has become aware that the controller units in the range mentioned above may not meet the labeled standard for protection against water or fluid ingress. some units have the potential to develop hairline cracks at the power ports of the controller housing. the cracks may allow for water or fluid ingress if the patient does not follow the instructions for use and the patient manual, including use of a water-resistant shower bag to help protect the unit. this can lead to varying degrees of controller malfunction, including pump stop.
according to the manufacturer, the cracks were found during manufacturer inspection of product under 10 x magnifications and are not visible without magnification. the root cause was determined to be a latent interaction between the materials used in the housing unit and the nitrile rubber gasket of the power port connector.
the manufacturer recommends the following patient manual instructions should be reinforced:
patients currently supported by the hvad system should follow all instructions in their patient manuals regarding water or fluid avoidance, which remain unchanged, and understand the importance of always using a shower bag when showering.
if a patient encounters a situation in which their hvad system controller is exposed to water or fluid outside of conditions described in the ifu and patient manual, the patient should be advised to contact his/her vad coordinator.
if further assistance is needed, clinicians should contact their local supplier.
the manufacturer and the independent practitioner quality panel do not recommend proactive controller exchanges as a result of this potential issue.
the manufacturer has since resolved this issue in the manufacturing process, and all newly distributed controller units are no longer susceptible to this materials interaction. no other hvad system components are susceptible to the issue.
according to the local supplier, the affected products are distributed in hong kong.
if you are in possession of the products, please contact your supplier for necessary actions.
posted on 31 august 2018.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notes supplémentaires dans les données
Medical Device Safety Alert
Cause
Medical device safety alert: beckman coulter lipase, uric acid, hdl-cholesterol, enzymatic creatinine assays
medical device manufacturer, beckman coulter, has issued a medical device safety alert concerning its following devices:
reference: lipase osr6x30; uric acid osr6x98; hdl-cholesterol osr6x87; enzymatic creatinine osr6x204
lot number: all lots
the manufacturer informed that napqi (n-acetyl p benzoquinone imine), a metabolite of paracetamol, causes negative interference with enzymatic creatinine osr6x204, hdl- cholesterol osr6x87, lipase osr6x30 and uric acid osr6x98 assays, at levels present in the serum/plasma of overdose patients. napqi in toxic concentrations may potentially lead to erroneously low results for enzymatic creatinine, hdl cholesterol, lipase and uric acid. the risk to patient safety of this event has been determined as remote for enzymatic creatinine and highly unlikely for the remaining assays. paracetamol itself does not interfere with the assays.
according to the manufacturer, no action is required by the laboratory. laboratories should be aware that there is a remote probability that napqi in toxic concentrations may potentially lead to erroneously low results for lipase, uric acid, hdl-cholesterol and enzymatic creatinine. the following statement will be added to the interfering substances section of the lipase, uric acid, hdl-cholesterol and enzymatic creatinine ifus (blosr6x30, blosr6x98, blosr6x87 and blosr6x204, respectively: "n-acetyl-p-benzoquillone imine (metabolite of paracetamol) will generate erroneously low results in samples for patients that have taken toxic doses of paracetamol. "
according to the local supplier, the affected products are distributed in hong kong.
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 29 august 2018.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notes supplémentaires dans les données
Medical Device Safety Alert
Cause
Medical device safety alert: alcon cypass micro-stent
medical device manufacturer, alcon, has issued a medical device safety alert concerning its cypass micro-stent. the locally affected devices are identified as follow:
model number: 241 (8065754001)
lot number: fg122017005, fg112017003 & fg112017005
the manufacturer is conducting a voluntary field safety corrective action (withdrawal) of all versions of the cypass micro-stent. the stent is indicated for use in the reduction of intraocular pressure in adult patients with mild to moderate primary open-angle glaucoma (poag).
the two-year compass study, which served as a basis for regulatory approvals of the cypass micro-stent for use in conjunction with cataract surgery, included an evaluation of endothelial cell loss (ecl). at two years post-surgery there was little difference in ecl between the cypass micro-stent and cataract surgery-only groups, and results were consistent with peer-review literature benchmarks of cataract-related ecl.
the compass-xt study was designed to collect safety data on the subjects who participated in the compass study for an additional three years, with analysis of the completed data set at five years post-surgery. at five years, the cypass micro-stent group experienced statistically significant endothelial cell loss compared to the group who underwent cataract surgery alone. a healthy corneal endothelium is responsible for corneal clarity, which is necessary for good vision. endothelial cells do not replicate, and when they are traumatized they are permanently lost. when the number of cells remaining goes below a critical threshold corneal edema (swelling) ensues. corneal decompensation frequently follows, leading to loss of corneal clarity and a subsequent decline in vision. treatment to regain corneal clarity often requires a corneal transplant.
based on information currently available, surgeons should consider the following recommendations for evaluating and managing patients who have been implanted with the cypass micro-stent:
the manufacturer recommends that all patients who have been implanted with a cypass micro-stent undergo post-operative gonioscopy (if not performed previously) to assess stent position, and periodic assessments of endothelial cell density using specular microscopy;
surgeons who are considering stent adjustment or removal should review the information in the cypass micro-stent instructions for use (ifu). healing response and progressive engagement of implant retention features must be factored into the decision to remove the cypass micro-stent after the immediate postoperative period (i.E., after 1 month postoperative). surgeons should consider less invasive intervention such as positional adjustment or trimming of the cypass micro-stent proximal end as a first alternative to device removal. it is highly recommended that surgeons consult the manufacturer prior to device removal;
after the immediate postoperative period, trimming of the proximal end of the cypass micro-stent may be considered when the anterior position of the stent appears likely to compromise corneal endothelial health. there is limited clinical data on the effects trimming may have on ecl. surgeons should consider the risks of further endothelial cell trauma caused by the trimming procedure against the potential benefits of the procedure. a procedure for stent trimming is set out in the ifu.
in addition, the manufacturer advises surgeons to immediately cease implanting the cypass micro-stent. affected users should quarantine any unused products and product removal is on-going.
according to the local supplier, the affected products are distributed in hong kong.
if you are in possession of the products, please contact your supplier for necessary actions.
posted on 29 august 2018.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notes supplémentaires dans les données
Medical Device Safety Alert
Cause
Medical device safety alert: vyaire medical tri-flo subglottic suction system
the united states food and drug administration (fda) has issued a medical device safety alert concerning tri-flo subglottic suction system [part number: cm28010; lot/serial numbers: 0001158835, 0001158836, 0001158837, 0001185564, 0001194114, 0004008255, 0004008256], manufactured by vyaire medical.
the manufacturer has discovered potential patient safety risk associated with the use of tri-flow subglottic suction system. the distal soft tip of the catheter has been identified as having the potential to break off during patient use and result in aspiration of a solid foreign body.
for details, please refer to the following fda website:
https://www.Accessdata.Fda.Gov/scripts/ires/index.Cfm?event=80508
if you are in possession of the products, please contact your supplier for necessary actions.
posted on 29 august 2018.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notes supplémentaires dans les données
Medical Device Safety Alert
Cause
Medical device safety alert: accuray cyberknife treatment delivery system
medical device manufacturer, accuray, has issued a medical device safety alert concerning its cyberknife treatment delivery system.
the manufacturer has discovered an issue related to specific batches of calibration film used with the ball-cube ii phantom in calibrating the cyberknife treatment delivery system (cyberknife system). the ball-cube ii phantom calibration film (ball-cube ii film) was not manufactured within necessary dimensions and may introduce up to 0.5mm of positional inaccuracy to the cyberknife system. this inaccuracy is within the 0.95mm specification for overall delivery accuracy of the cyberknife system. however, it is an additional source of error that when added to other sources of error may exceed the expected positional tolerance of the system.
according to the manufacturer, only the ball-cube ii film manufactured from 1 august 2017 to 31 july 2018 and labeled with "ashland" are affected. most systems calibrated using the affected bait-cube ii film will still operate within the 0.95mm overall delivery accuracy. a small portion of systems may have up to a 1.45mm error in positional accuracy.
the affected users are recommended to take the following actions to ensure cyberknife system positional accuracy is within specifications:
stop using and quarantine the affected products.
the new ball-cube ii film provided with the customer letter can be used to perform both a 6d skull and fiducial end-to-end test to preliminarily assess the positional inaccuracy.
if the results do not meet the acceptance criteria, they should contact the manufacturer to schedule service.
product removal and replacement are on-going.
according to the local supplier, the affected products are distributed in hong kong.
if you are in possession of the products, please contact your supplier for necessary actions.
posted on 28 august 2018.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notes supplémentaires dans les données
Medical Device Safety Alert
Cause
Medical device safety alert: boston scientific accolade family pacemakers
medical device manufacturer, boston scientific, has issued a medical device safety alert concerning its accolade family pacemakers, the devices are identified as follow:
product: a) single chamber pacemakers; b) dual chamber pacemakers; c) cardiac resynchronization therapy pacemakers (crt-ps)
model: a) l200 proponent pacemakers, s701 altrua 2 pacemakers; b) l121 essentio pacemakers, s702 altrua 2 pacemakers, s722 altrua 2 pacemakers; c) u128 valitude crt-p
during a review of warehouse inventory, a discrepancy was identified between the box/tray label and the nominal device values shown on the programmer screen(s) for an accolade family pacemaker. further investigation identified the following errors on box and tray labels for certain accolade family pacemakers and crt-ps:
for single chamber, dual chamber and crt-p models, the box and tray labels for nominal ventricular amplitude reads (3.5mv). the correct value is (3.5v);
for single chamber models, the box and tray labels include a value for paced av delay and sensed av delay. they should not be included on the labels, as they do not apply for single chamber devices;
for single chanber models, the box and tray labels for the ventricular refractory rv (max/min) read 250ms/230ms. the correct value is 250ms/250ms.
the manufacturer has determined that this is a box and tray labeling discrepancy and has no impact on device or programmer performance. the nominal parameters printed on the table are not options available for programming by the user when the device is programmed in vvi mode (at nominal settings). there is no foreseeable risk to patient safety. the affected inventory may be safely implanted and used with the accompanying documentation.
according to the local supplier, the affected box and tray labels are only on product distributed in china. accolade pacemakers and crt-ps distributed to other countries do not include the affected nominal settings table on the box/tray. there is no affected customer in hong kong.
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 24 august 2018.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notes supplémentaires dans les données
Medical Device Safety Alert
Cause
Medical device safety alert: biomerieux vitek 2 gram positive antimicrobial susceptibility testing (ast) cards
the united states food and drug administration (fda) has issued a medical device safety alert concerning vitek 2 gram positive cefoxitin screen and vitek 2 gram positive ast for oxacillin [lot numbers: all lots of gram positive ast cards with oxacillin and cefoxitin tests; manufacturing and distribution dates: 8 february 2017 to present], manufactured by biomerieux.
the manufacturer is recalling the affected products because of false negative or false susceptible results for some strains of methicillin-resistant staphylococcus aureus (mrsa). it is continuing to investigate the issue to determine the root cause of the failure and the prevalence of the strains that are subject to erroneous results.
according to the manufacturer, missed diagnosis and inappropriate treatment of mrsa could cause severe health consequences, including lack of treatment for a mrsa infection, and death.
the manufacturer recommends that labs confirm potential mrsa upon activation of the software bioart rule. the mrsa safety alert letter is issued directing labs to:
implement a custom vitek 2 system software bioart rule to aid in mitigating potential non-detection of mrsa when testing oxacillin (ox) and cefoxitin screen (oxsf) on vitek 2,
enable the advanced expert system on the vitek 2 systems software to ensure that the appropriate forcing rules are applied to test results regardless of the parameter set in use, and
use the existing strain submission system to send isolates of suspect strains of mrsa to the manufacturer for additional testing.
for details, please refer to the following fda website:
https://www.Fda.Gov/medicaldevices/safety/listofrecalls/ucm618135.Htm
if you are in possession of the products, please contact your supplier for necessary actions.
posted on 24 august 2018.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notes supplémentaires dans les données
Medical Device Safety Alert
Cause
Medical device safety alert: william cook europe zenith alpha thoracic endovascular graft
medical device manufacturer, william cook europe, has issued a medical device safety alert concerning its zenith alpha thoracic endovascular graft (catalogue identifier: all zta-devices).
the manufacturer has become aware that the zenith alpha thoracic endovascular graft has been used to treat patients with thoracic aortic dissections.
as per instructions for use (ifu), the graft is indicated for the endovascular treatment of patients with aneurysms or ulcers of the descending thoracic aorta having vascular morphology suitable for endovascular repair, including:
iliac/femoral anatomy that is suitable for access with the required introduction systems;
nonaneurysmal aortic segments (fixation sites) proximal and distal to the thoracic aneurysm or ulcer: with a length of at least 20 mm, and with a diameter measured outer-wall-to-outer-wall of no greater than 42 mm and no less than 20 mm.
to emphasize best practices, the manufacturer would like to reiterate that the graft and ancillary components should be used as specified in the ifu. the ifu section 4.2 “patient selection, treatment and follow up” states that the safety and effectiveness of the zenith alpha thoracic endovascular graft and ancillary components have not been evaluated in the patient populations for dissection. users are also advised to refer to ifu section 5 for potential adverse events associated with either zenith alpha thoracic endovascular graft or the implantation procedure that may occur and/or require intervention.
according to the manufacturer, no devices are needed to be returned and patients already treated for a dissection should receive standard follow up procedures.
according to the local supplier, the affected products are distributed in hong kong.
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 23 august 2018.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notes supplémentaires dans les données
Medical Device Safety Alert
Cause
Medical device safety alert: eurogine s.L. intrauterine devices (updates)
medical device manufacturer, eurogine s.L., has issued a medical device safety alert concerning its intrauterine devices (iud). the affected devices are identified as the following: -
model: ancora [lots: 0114, 0614, 1114, 0415]:
ref. 01030000 ancora 375 cu normal
ref. 01030400 ancora 375 ag normal
ref. 01030200 ancora 250 cu mini
iud to be replaced as preventive action [lots: 1115, 0616, 1116, 0216, 0217, 0417, 0917, 1113, 0114, 0614, 0415]:
ref. 01010500 novaplus t 380 ag normal
ref. 01010600 novaplus t 380 ag mini
ref. 01010700 novaplus t 380 ag maxi
ref. 01020100 novaplus t 380 cu normal
ref. 01020200 novaplus t 380 cu mini
ref. 01030000 ancora 375 cu normal
ref. 01030400 ancora 375 ag normal
ref. 01030200 ancora 250 cu mini
ref. 01040000 gold t maxi
ref. 01040100 gold t normal
ref. 01040200 gold t mini
an increase in breaks in the horizontal arms (one or both) was observed at the time of the extraction of the iud model ancora. after the investigation carried out, it can be concluded that the main cause that has generated this situation is a deficient manufacturing of the raw material by the manufacturer/supplier. the mixture between the polymer and barium sulphate was correct in proportion, but agglomerates have appeared in a random way that can embitter the product, in spite that this parameter is controlled and certified by the manufacturer of the raw material.
according to the manufacturer, the reported ruptures have mostly occurred at the moment of the extraction of the iud and in the same area of the structure that is the angle of union of the horizontal arms with the vertical axis. this is the part that suffers the greatest mechanical stress in all the iuds in "ω" shape, at the time of insertion but especially in the extraction. the combination between the extraction system (torsion of the arms) and possible agglomerations of barium sulphate in the torsion zone can cause the breakage of the device.
based on the current data and the nature of the breakage, the efficacy of the iud is not affected and therefore premature removal of the device is not recommended. for programmed extractions, it is recommended to perform a slow and constant traction when pulling the threads.
in the event that a rupture should occur and a fragment remains inside the uterus, monitor by ultrasound and assess at the physician's discretion the possibility of:
wait for a sufficient period of time to allow the spontaneous expulsion of the fragment during menstruation.
if it does not occur, remove the fragment with a mathieu extractor gripper or similar through the cervical canal
in the last case, assess the need to perform a hysteroscopy to remove the fragment
according to the local supplier, the affected products are distributed in hong kong. besides, the local supplier has received several reports of adverse incidents associated with the additional lots happened in past few months with the same cause which triggered the recall. therefore, the affected users are recommended to stop using the affected products on hand.
product replacement is on-going.
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 22 august 2018.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notes supplémentaires dans les données
Medical Device Safety Alert
Cause
Medical device safety alert: beckman coulter unicel dxh 800 coulter cellular analysis system and unicel dxh 600 coulter cellular analysis system
medical device manufacturer, beckman coulter, has issued a medical device safety alert concerning its following devices:
unicel dxh 800 coulter cellular analysis system [reference: 629029, b24465, b24802, b68304, b66445, b63322; software version: 3.2.0 and below];
unicel dxh 600 coulter cellular analysis system [reference: b23858; software version: 1.3.0 and below].
the manufacturer has confirmed complaints of sporadic erroneously elevated platelet results without flags or system messages. other parameters are not affected by the issue.
patient results may be affected. no injury has been reported in association with the issue.
during patient’s follow-up, the affected users are advised to consider unexpected elevated platelet levels as possible erroneous results due to the failure and ensure implementation of the following actions:
use all available features to assess patient results, including reference ranges, action and critical limits, instrument system flags, codes, messages, delta checks, xm, and decision rules;
follow their laboratory’s standard operating procedure for confirming unexpected results;
communicate to their medical director the need to avoid patient treatment based solely on any single test result, and to interpret all results in the context of other clinical and laboratory features;
consult with the medical director to determine if a retrospective review of results is warranted.
according to the manufacturer, dxh 800 version 3.2.1 and dxh 600 version 1.3.1 are not affected by the issue. the manufacturer will be prioritizing the upgrades for the systems.
alternatively, the manufacturer is working on the development of a self-installable software patch option, in lieu of the software upgrade, to expedite resolution and minimize impact on laboratory workflow.
according to the local supplier, the affected products are distributed in hong kong.
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 10 august 2018.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notes supplémentaires dans les données
Medical Device Safety Alert
Cause
Medical device safety alert: bausch & lomb stellaris elite single port vitrectomy cutters
the united states food and drug administration (fda) has issued a medical device safety alert and a letter to health care providers concerning risks associated with use of rupture of membrane tests.
the fda has alerted women and their doctors about serious adverse events related to the improper use of tests intended as an aid in detecting if a rupture of the membranes (rom) containing amniotic fluid. a rom can pose immediate and severe risks to the patient and developing fetus without proper patient management and timely intervention.
the fda has received information which indicates that health care providers may be relying solely on rom test results when making critical patient management decisions, despite manufacturers’ labeling instructions that rom tests should not be used on their own to independently assess whether a rom has occurred.
the fda is concerned about misuse, over-reliance, and inaccurate interpretation of lab test results from rom tests used to detect rupture of membranes in pregnant women. these can lead to serious adverse events, including fetal death, infection, and other health complications in pregnant women.
the fda has become aware of adverse events related to the use of rom tests, including 15 fetal deaths and multiple reports of health complications in pregnant women. the test may provide a false negative result; without additional clinical assessment, providers may incorrectly assume rom has not occurred.
the fda is reminding health care providers that tests to detect rupture of the amniotic membranes should not be used without other clinical assessments to make critical patient management decisions. health care providers using rom tests should be aware of test limitations listed within manufacturer instructions. the following limitations are typically stated in rom device labeling:
a negative result does not assure the absence of membrane rupture;
false negatives may result if the amniotic sac has resealed or the position of the fetus has obstructed the rupture;
the presence of blood, meconium, anti-fungal creams or suppositories, baby powder, baby oil, or the use of lubricant with a vaginal exam may interfere with the device; and
the test may not be accurate if sample collection and testing occurs after the timeframe recommended by the manufacturer.
to help protect patients and reduce the chance of adverse events, rom tests should be part of an overall clinical assessment, which may include physical examination of the patient and testing to detect leaking amniotic fluid.
the fda is also urging pregnant women who may be concerned about amniotic membranes that may have ruptured too early, which can be characterized by either a rapid release of amniotic fluid or a small trickle, to contact their healthcare providers right away. patients should speak with their healthcare providers about the signs and symptoms of rom.
in addition, the fda is separately notifying the public of a voluntary recall for one brand of these products, the amnisure rom test strips, distributed between october 2017 and march 2018. these devices do not exhibit a control line, making it potentially difficult for healthcare providers to interpret the results of the test. the fda will continue to communicate with the manufacturer, qiagen sciences, regarding the recall of these products and will provide updated information if it becomes available. according to the local supplier, the affected products are not distributed in hong kong. the recall is unrelated to the improper use of the tests and the fda is not aware of device malfunctions associated with any other rom tests made by other manufacturers.
for details, please refer to the following fda websites:
https://www.Fda.Gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ucm616220.Htm
https://www.Fda.Gov/medicaldevices/safety/letterstohealthcareproviders/ucm616128.Htm
https://www.Fda.Gov/newsevents/newsroom/pressannouncements/ucm616137.Htm
if you are in possession of the products, please contact your supplier for necessary actions.
posted on 9 august 2018.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notes supplémentaires dans les données
Medical Device Safety Alert
Cause
Medical device safety alert: bausch & lomb stellaris elite single port vitrectomy cutters
medical device manufacturer, bausch & lomb, has issued a medical device safety alert concerning its stellaris elite single port vitrectomy.
the manufacturer is conducting a voluntary recall of 29 lots of the affected products in gauge sizes 20, 23 and 25 after receiving a limited number of customer reports of the back cap separating from the body of the cutter during surgery. no reports of patient injury have been reported as a result of these incident.
according to the manufacturer, the vitrectomy cutter handle is assembled by press-fitting the back cap to the vitrectomy cutter body. bonding agent is then applied to the handle seam where it wicks into the assembly interface. during operation the seal joint can be exposed to a maximum internal pulse pressure of 42 psi.
probable cause for the failure has been identified as insufficient bonding agent between vitrectomy cutter back cap and body. quality change request was initiated to further investigate and improvements to the bonding process have been implemented during production.
product replacement is on-going.
according to the local supplier, the affected products has been imported in hong kong. the impacted lots, however, are not released to market and are held in its warehouse. they are identified as below:
20ga 7.5k pneumatic vit cutter [part number: bl5626; lot number: v9400]
23g post elite w mf 6/bx [part number: se5423mv; lot number: w1721, w0147]
23g post elite w wf 6/bx [part number: se5423wv; lot number: w0148]
25g post elite w wf 6/bx [ part number: se5425wv; lot number: w0157]
23g combo elite w mf 6/bx [part number: se5523mv; lot number: w0783]
25g combo elite w mf 6/bx [part number: se5525mv; lot number: w0787]
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 7 august 2018.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notes supplémentaires dans les données
Medical Device Safety Alert
Cause
Medical device safety alert: medtronic capnostream 20 and capnostream 20p bedside patient monitors
medical device manufacturer, medtronic, has issued a medical device safety alert concerning its capnostream 20 and capnostream 20p bedside patient monitors.
the manufacturer has received customer reports that the date/time, nurse call and alarm settings of capnostream 20 and capnostream 20p bedside patient monitors may reset to the factory default settings when the monitor is powered off. there have been no reports of patient injury related to this issue.
investigation revealed that the cause for the reset to the factory default settings is the accelerated discharge of the internal coin cell battery. user-defined institutional default settings are not lost if the monitor is not powered off, even when the internal coin cell battery is depleted. this issue does not affect the operation of the monitor’s removable li-ion battery or any other aspect of the monitor’s operation. only the reset of user-defined institutional default settings as described are affected.
the manufacturer is developing a software update that will ensure user-defined institutional default settings are not lost if the monitor is powered off, except the date/time, regardless of the internal coin cell battery charge level. this software update will be available in october 2018. affected user should download the software update from the manufacturer’s website when it is available.
the manufacturer will issue an update to the operator’s manual to note that the date/time setting should be verified at power on. the manufacturer is recommending continued use of capnostream devices. users should confirm that the date/time is accurately displayed. if the date/time requires reset, all user defined settings, such as alarms and nurse call, will also require reset until the software is updated. affected users should follow the instruction in the operator’s manual to set user-defined default settings.
according to the local supplier, the affected products are distributed in hong kong.
if you are in possession of the products, please contact your supplier for necessary actions.
posted on 6 august 2018.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notes supplémentaires dans les données
Medical Device Safety Alert
Cause
Medical device safety alert: durex polyisoprene (pi) synthetic latex condoms
medical device manufacturer, reckitt benckiser, has issued a medical device safety alert concerning its durex polyisoprene (pi) synthetic latex condoms.
the manufacturer recently found that a small number of pi synthetic latex condoms made earlier this year are not passing its stringent quality tests.
according to the manufacturer, the tests have shown that while all pi synthetic latex condoms which are currently on the market in all countries are expected to be above the international quality standard (iso 23409:2011) for male condoms of this type, recently a small number of condom batches did not pass retesting against the more stringent quality standard. there have been no adverse events reported in relation to any of these batches of condoms and there is no immediate safety concern for consumers, and the issue does not present a significant or unacceptable risk. product recall is on-going.
according to the local supplier, the events do not impact any pi synthetic latex condoms, namely durex real feel condoms, that are marketed in hong kong. all batches of durex pi synthetic latex condoms sold in hong kong have been retested and stress tested and continue to meet the stringent quality requirements for quality.
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 30 july 2018.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notes supplémentaires dans les données
Medical Device Safety Alert
Cause
Medical device safety alert: biomerieux vidas ca 15-3
medical device manufacturer, biomerieux, has issued a medical device safety alert concerning its vidas ca 15-3 [reference: 30429; lot number: 1006022590 and 1006251930].
following customers’ complaints for calibrations out of range (standard s1 out of range low and/or control c1 out of range high) when using the affected lots, investigators confirmed a defect on the identified products and reproduced the issue reported by the customers.
the manufacturer has identified that s1 signal decrease was probably due to a particular lot of raw material (bovine albumin) which is a component of standard s1, which was not performing as expected. the lot of raw material was not used for the manufacturing of any other product. it has been established that standard s1 will continue to decrease over time, what will lead both lots of finished products to be unusable due to invalid calibrations.
investigators showed that control c1 is conforming expected specifications. its relative fluorescence value (rfv) does not evolve overtime. the c1 out of range high reported by some customers is not linked to a signal increase but is due to standard s1 decrease.
according to the manufacturer, as the vidas systems trigger an alarm in case of invalid calibration, the defect is easily identified. the identified issue can lead to delayed results. there is no risk for false results.
the defect (standard s1 signal decrease) can have two impacts on the finished product:
standard s1 is obtained out of range low at the opening of the kit: the kit cannot be calibrated and cannot be used, what leads to delayed results.
control c1 is obtained out of range high at the time of the recalibration: the kit cannot be calibrated and cannot be used, what leads to delayed results.
affected users are instructed to destroy the impacted lots.
according to the local supplier, the affected products are distributed in hong kong.
if you are in possession of the products, please contact your supplier for necessary actions.
posted on 18 july 2018.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notes supplémentaires dans les données
Medical Device Safety Alert
Cause
Medical device safety alert: brilliance 64, brilliance ict, brilliance ict sp, ingenuity core, ingenuity core128, ingenuity ct, brilliance ct bigbore and iqon spectral ct
medical device manufacturer, philips electronics hong kong ltd., has issued a medical device safety alert concerning its products as follow:
a) brilliance 64, brilliance ict, brilliance ict sp, ingenuity core, ingenuity core128, and ingenuity ct with software version 4.1.6;
b) brilliance ct bigbore and with software version 4.2.0;
c) iqon spectral ct with software versions 4.7.0 and 4.7.2.
the manufacturer reported that scanners running software versions 4.1.6 (brilliance ict and ingenuity ct), 4.2 (brilliance bigbore), and 4.7.0 and 4.7.2 (iqon) with the heartbeat cs pro option provide confusing information in the “impressions” section of the heartbeat calcium score report.
according to the manufacturer, the generated report provides multiple analyses of the amount of plaque detected, as if they all apply to the patient at the same time. the user cannot modify the content of the template to create user-tailored formats nor can they edit the reports generated from the template to remove/correct information. in addition, the report includes blank table cells that the customer is unable to edit using preferences.
the manufacturer is aware of the users’ concerns with the confusing content and inability to edit the reports and is working to address them appropriately:
fco72800660 has been released to update the brilliance ct bigbore to software version 4.2.1 which resolves this issue;
fco72800689 has been released to update the iqon to heartbeat release version 4.7.5 which resolves this issue;
fco72800675 has been released to update the brilliance 64 and ingenuity ct/core/core128 to heartbeat release version 4.1.7 which resolves this issue;
fco72800678 has been released to update the brilliance ict and ict sp to heartbeat release version 4.1.7 which resolves this issue.
for users, it is reminded that the "impressions" section of the report is not intended for diagnostic use. when determining treatment, the user should focus on the total calcium score shown in the "findings" section, the coronary artery score(s), and/or the "age and gender" graph as identified in the instructions for use (ifu).
for further information on the calcium scoring application, users can refer to the following applicable ifu:
459801063511_d–ict family - instruction for use (ifu)–section 10–using analysis packages–heartbeat calcium scoring (hbcs);
459801063521_d–ingenuity family - instruction for use (ifu)–section 10–using analysis packages– heartbeat calcium scoring (hbcs);
459801063531_d–brilliance ct 64-channel - instruction for use (ifu)–section 10–using analysis packages – heartbeat calcium scoring (hbcs);
459800917202_c–iqon spectral ct - instruction for use (ifu)–section 10–using analysis packages– heartbeat calcium scoring (hbcs);
459800863011_d–brilliance ct big bore - instruction for use (ifu)–section 10–using analysis packages –heartbeat calcium scoring (hbcs).
according to the local supplier, the affected products are distributed in hong kong.
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 24 july 2018.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notes supplémentaires dans les données
Medical Device Safety Alert
Cause
Medical device safety alert: intragastric balloon systems
the therapeutic goods administration (tga) of australian government has conducted a product safety review of two intragastric balloon systems on the australian register of therapeutic goods, including orbera intragastric balloon system (manufactured by apollo endosurgery) and reshape integrated dual balloon system (manufactured by reshape lifesciences). tga's review follows information published by food and drug administration (fda) of the united states about deaths and serious injuries to patients associated with use of intragastric balloons to treat obesity.
tga has received 19 adverse event reports since 2009 regarding the intragastric balloon systems that are currently being supplied in australia. these reports include three patient deaths. tga is working with sponsors and manufacturers to ensure clinicians and patients are fully informed of the risks with this type of device.
information for health professionals and patients as below:
if doctors are treating a patient who has an intragastric balloon, be alert to symptoms that might indicate there is an issue associated with the device. adverse events associated with these devices include:
obstruction;
ulceration;
necrosis;
ischaemia (gastric or intestinal);
spontaneous hyperinflation of the balloon;
perforation (oesophageal, gastric or intestinal);
gastritis/ gastric erosions;
acute pancreatitis.
where relevant, patients should be advised to take the necessary precautions to prevent pregnancy prior to placement and throughout the duration of treatment, and be instructed to inform doctors as soon as possible if pregnancy is confirmed during treatment, so that removal of the device can be arranged.
tga recommends that doctors monitor patients closely during the entire term of treatment with intragastric balloon systems for possible complications. in particular, be aware that patients with an intragastric balloon who present with severe abdominal pain and have a negative endoscopy and x-ray, may still require a ct scan to definitively rule out a perforation.
an intragastric balloon should not be used in patients who:
are under 18 years of age;
have had previous upper gastrointestinal surgery;
regularly take aspirin, non-steroidal anti-inflammatory agents, cox-2 inhibitors, anti-coagulants or anti-platelet agents;
are pregnant;
have a clinically significant hiatus hernia;
have a history of inflammatory disease of the gastrointestinal tract.
there are other conditions that may also preclude use of an intragastric balloon, and so it is important that patients discuss complete medical history with doctors.
if they or someone they provide care for has an intragastric balloon system in place, be alert to potential issues. complications (mentioned in the adverse events), although rare, may require abdominal surgery, or have serious consequences including death.
symptoms to watch out for include persistent or recurrent abdominal pain, swelling of the abdomen, vomiting, difficulty breathing or back pain. do not ignore these symptoms and seek medical attention as soon as possible.
for detailed information, please refer to tga website https://www.Tga.Gov.Au/alert/intragastric-balloon-systems.
posted on 18 july 2018.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notes supplémentaires dans les données
Medical Device Safety Alert
Cause
Medical device safety alert: biomerieux bact/alert virtuo systems
medical device manufacturer, biomerieux, has issued a medical device safety alert concerning its bact/alert virtuo systems [a) bact/alert virtuo a unit; b) bact/alert virtuo b unit; c) bact/alert virtuo a unit china; reference: a) 411660; b) 411661; c) 419947].
the manufacturer has identified an anomaly of the bact/alert virtuo instrument firmware version r2.0, which allows relocation of the four resident calibration standards so that field system engineers can service the associated cells p24 – p27, where the calibration standards typically reside. if the calibration standards are not returned to the designated locations, the anomaly may occur.
following a reboot via the instrument’s small user interface screen, while patient or test bottles are loaded in cells p24 – p27, the following will occur:
the unload date/time will be set to the current date/time, causing the bottle status to be set to “unload” even though the bottle remains in the instrument.
the bottle will continue to process; however, in the event of a positive bottle in cells p24 – p27, no indication of a positive bottle will be observed by the user. neither the visual (flashing yellow light) nor audible alarm will occur.
although the instrument does not provide alarm, the bottle result is transferred to the laboratory information system.
two consecutive error conditions may also be observed for bottles in cells p24 – p27:
an “anonymous bottle” alarm.
a “duplicate bottle” alarm.
according to the manufacturer, there is the potential for delayed culture bottle results due to the described anomaly if the user does not open the instrument door and manually unload the positive bottle so that the gram stain and subculture can be performed. a delay in the context of a patient with a bloodstream infection (positive culture) could delay diagnosis and/or life-saving medical interventions and the initiation of (or modification of existing empiric) antibiotics. additionally, extended clinical uncertainty during a reporting delay could subject a patient to unnecessary therapeutic and/or diagnostic procedures.
in the interim, the users are advised to be vigilant when reviewing alarms for anonymous and/or duplicate bottles. if they become aware of a patient/test bottle loaded into cells p24 – p27, notify the local supplier. viewing or printing bottle reports will show accurate bottle results for positive and negative bottles, including patient/test bottles located in cells p24 – p27.
according to the local supplier, the affected products are distributed in hong kong.
if you are in possession of the products, please contact your supplier for necessary actions.
posted on 12 july 2018.