Recall Z-1151-2021 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Baxter Healthcare Corporation
The PrisMax System Version II Hemodialysis Delivery System: Automatic Repositioning System Pump Assembly, specifically tubing, Model Numbers: a) 955626 b) 955558 c) 955701 PrisMax V2 Preventive Maintenance Kit, Product Code SC616 ARPS PUMP, Product Code SC6035 ARPS Pump Assembly, Product Code SC6053
| Date | Jan 7, 2021 |
| Status | Terminated |
| Reason | Variability in the performance of the tubing in the ARPS (Automatic Repositioning System) Pump Assembly which may lead to alarm situations during system self-test and therapy. This tubing is normally replaced during annual preventative maintenance. Alarm Situations: During System Self-Test: Alarm code B1215 (ARPS Self-Test failure); During Therapy: B1273 (ARPS Leak), B1215 (ARPS Pressure self-test), B1116 (Return Pressure self-test Failure), B1539 (Access Pod Reposition Failure), B1541 (Effluent Pod Reposition Failure), B1540 (Effluent Filter Pod Reposition Failure). If an alarm occurs, it m |
| Root cause | Under Investigation by firm |
| Action | Baxter sent An Urgent Medical Device Correction letter dated January 7, 2021. To prevent potential alarm situations, the affected tubing in the ARPS Pump Assembly for the PrisMax devices will be replaced with improved tubing. Operators may continue to safely use the PrisMax System until the tubing is replaced within the ARPS Pump Assembly. If an alarm occurs, the PrisMax System will default to a safe state and the user should follow the on-screen instructions to end treatment and to contact service. A local Baxter service representative will contact each facility to determine the correction p |
| Quantity | 2314 units |
| Distribution | Worldwide distribution - US Nationwide distribution including in the states of AR, AZ, CA, CO, CT, FL, GA, HI, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NY, OH, OR, PA, SD, TN, TX, UT, VA, WA, WI and the countries of Australia, Austria, Belgium, Canada, China, Croatia, Denmark, Fin |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K190910 | PrisMax System Version 2 Baxter Healthcare Corp, Jul 25, 2019 |