| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00243-1 |
| Product Name/Description |
Ultrafilter U9000 for use with AK96 and AK98 v1 dialysis machines
Product Code:112062
Lot numbers: 6-1907-H-01 and higher (all unexpired units)
ARTG Number: 131741
(Baxter Healthcare - Filter, intravenous line) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
27/03/2018 |
| Responsible Entity |
|
| Reason/Issue |
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. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
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.
Update April 2019:
Baxter will contact remaining facilities to schedule the reset rather than waiting for scheduled preventative maintenance.
Baxter is also providing customers with examples of weekly disinfection programs on Baxter dialysis machines.
This action has been closed out on 09/04/2021 |
| Contact Information |
03 9389 3058 - Clinical Sales Specialist |