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: 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: 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: 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: 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: 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: 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: 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: 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.