Ultrafilter U9000 for use with AK96 and AK98 v1 dialysis machines 의 리콜

Recall

RC-2018-RN-00243-1

Class I

2018-03-27

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00243-1

Baxter healthcare corporation has identified potential leaks during regular clinical use of the ultrafilter u9000. the leaks are caused by cracks near the header cap due to the stress of repeated disinfection cycles over the lifetime of the product. the current instructions for use (ifu) state the ultrafilter has a maximum lifetime usage of 90 days, or 150 heat disinfection cycles, with a maximum of 8 sodium carbonate and 12 sodium hypochlorite disinfection cycles. in order to reduce the patient risk associated with the occurrence of leaks, the ifu will be updated to reduce the maximum lifetime usage to 60 days, or 100 heat disinfection cycles, with a maximum of 8 sodium carbonate and 12 sodium hypochlorite disinfection cycles when the ultrafilter is used in conjunction with ak96 and ak98 v1 dialysis machines. other machines using these filters have a leak detector sensor that will trigger an alarm.

Baxter is advising that operators may continue to use affected units with AK96 and AK98 v1 dialysis machines according to the new maximum lifetime usage criteria of 60 days, or 100 heat disinfection cycles, with a maximum of 8 sodium carbonate and 12 sodium hypochlorite disinfection cycles. If Ultrafilters currently in use with AK96 and AK98 v1 machines have exceeded any of the new maximum lifetime usage criteria, it is recommended the filter be changed. Baxter will reset the AK 96 & AK 98 v1 monitor counters to the reduced maximum usage during the next scheduled preventive maintenance.