Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
Notes supplémentaires dans les données
Cause
The hd-paed option is available for dialysis 5008 systems for patients with a lower body weight. fresenius medical care has undertaken a review of the hazards identified with the use of the hd-paed option and determined that it is no longer possible to uphold the currently defined lower limit of 10 kg of body weight in the intended use for a safe application. as a result, fresenius medical are limiting the intended use to = 17 kg of body weight.To date, no related incidents for patients between 10kg and 40kg have been reported.
Action
Fresenius Medical Care is advising that the intended use of the HD-PAED option has been revised to = 17 kg of body weight. The Instructions For Use (IFU) of the 5008 Paediatric Haemodialysis Therapy System will be adapted accordingly. Customers are requested to exchange the relevant page in the IFU with the addendum included with the Customer Letter.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
Notes supplémentaires dans les données
Cause
Getinge have identified an issue which may result in a lack of drying/storage of restrictive endoscopes when they are placed in the eds8. this potential for malfunction is caused by a device design issue. it is identified that the delivered pressure and flow rate of the eds8 compressor is too low. under certain conditions (drying/storage of a restrictive endoscope), the compressor may not be powerful enough to reach the 5l/min airflow required to properly dry/store the endoscopes.Getinge have received several complaints related to this issue, but there was no reported user or patient injury.
Action
Getinge have developed a compressor with a higher flowrate to correct this issue. Getinge will contact users to arrange replacement of the current compressor.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
Notes supplémentaires dans les données
Cause
Radiometer has recently become aware that the abl800 series analysers that measure ccrea may potentially report lower than expected ccrea results on patient samples. the difference has been reported to be as high as -28%.Currently, this problem may not identified by running the qc, as the qc will be lower, but still within range.The underestimated creatinine occurs specifically when measurements on autocheck 6+ level 1 (also known as s7835 autocheck module and abbreviated ac6+l1) are = 230 µm of a specified insert interval for ac6+l1 with insert limits 210–290 µm. ultimately, a lower read-out on patient samples on abl8x7 is observed.This issue may lead to erroneous measurement values for ccrea, and may lead to no detection of renal insufficiency or underestimation of moderate to severe renal failure.
Action
Radiometer requests that users do not report cCrea results until they have verified the performance of the membrane units as described in the Customer Letter.
Radiometer is advising that they are improving the cCrea membranes and will advise users accordingly when interim measures are no longer required.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
Notes supplémentaires dans les données
Cause
Zimmer biomet, on behalf of lmt surgical, has been made aware via complaint investigation that unexpected lumen may be present in the interface of the handle with the metal chisel. products exhibiting this issue would not be able to be reprocessed with the validated reprocessing cycles.
Action
Zimmer Biomet is advising customers to return all affected product.
This item is no longer supplied in Australia.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
Notes supplémentaires dans les données
Cause
During internal investigations, roche diagnostics confirmed that in rare cases, sample material may come in contact with the pipetting nozzle during operation of the cobas p 612 pre-analytical system. this may lead to contamination of samples and, if a highly sensitive analytical technology is used e.G. molecular testing, inaccurate results may be produced.Cobas p 612 pre-analytical systems that use disposable filter tips are not affected by this issue.Roche has received no complaints worldwide for this issue; none from australian customers to date.
Action
Roche Diagnostics Australia is advising that the use of disposable filter tips in the cobas p 612 pre-analytical system will be mandatory until the root cause is identified and appropriate corrective actions have been implemented. Roche Diagnostics Australia will contact laboratories in due course to arrange the modifications required for using disposable filter tips.
The root cause investigation is still ongoing. Roche will send an update as soon as the root cause is identified and corrective measures are available.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
Notes supplémentaires dans les données
Cause
On a subset of platinium icd and crt-d devices, a specific hardware configuration was identified as potentially defective over time, leading to overconsumption, immediately followed by loss of pacing and sensing capabilities in all cavities. as a result of the loss of sensing capability, the device cannot identify an arrhythmia that would require a defibrillation shock therapy.No permanent injury or death has been reported as a result of this issue.
Action
Microport CRM is initiating a removal of the non-implanted Platinium devices that may present with this hardware failure and providing recommendations for managing implanted patients; and
In order to mitigate the potential risks associated with the loss of the device pacing and sensing capabilities, Microport CRM recommends physicians follow-up the patients at the periodicity already stated in the implant manual.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
Notes supplémentaires dans les données
Cause
The perifix catheter connector is a connection device used by clinicians to provide various anaesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anaesthetics. in the course of our regular post market surveillance activities we have found that the perifix catheter connector may not remain closed during use. in some cases this has led to leakage or disconnection of the catheter from the perifix catheter connector. while no serious injuries to patients, users, or third parties have been reported to date, there is a possibility of contamination of the catheter or delay of anaesthesia of different severity.
Action
Users are asked to:
Review the customer letter in its entirety and ensure that all users of these products in your organization and other concerned persons are informed about this Medical Device Correction.
If you are a distributor, please forward the customer letter to your customers.
For continued safe use of the Perifix Catheter Connector, users are asked to review and follow the instructions described in Appendix 1 of the customer letter.
Confirm receipt of the customer letter by completing the supplied confirmation slip and return it as per the instructions given.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
Notes supplémentaires dans les données
Cause
Radiometer has recently become aware that the abl800 series analysers could potentially induce a patient mix-up when “confirmation of demographics” is enabled as part of the query to aqure, radiance, or a his lis system. please note that the default setting for this function is ‘disabled’.The described error may potentially impact upon patient management as the physician may subject the patient to unnecessary treatment or erroneously withhold necessary treatment from the patient based upon the mixed-up of patient identification. in a worst-case scenario, where a critical parameter, such as k+ or po2, is interrogated, based upon a false clinical diagnosis inferred from the erroneous measurement, a critically ill patient may be subjected to lack of critical treatment.
Action
Radiometer is advising that they are currently working on revising the software to correct this issue. Once release, a Radiometer representative will contact users to schedule a visit for the software upgrade.
In the interim, users are requested to confirm if "Confirmation of Demographics" is disabled on their analysers. If disabled, the issue will not be experienced. If enabled, one of the two following counter-measures (CM) must be implemented:
CM #1: Disable “Confirmation of Demographics” as follows:
a. Logon to the analyzer.
b. Select “Menu” > “Utilities” > “Setup” > “General Setup” > “Communications” > “Automatic Data Request”
c. Remove the checkmark for “Confirm requested data”, if present.
d. Select “Close”.
Or
CM #2: If disabling the “Confirmation of Demographics” (CM #1) is not possible due to e.g. internal procedures, instruct all operators of the analyser(s) to not introduce a new sample when the menu for “Confirmation of Demographics” is being displayed.