Recall Z-1925-2018 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Baxter Healthcare Corporation
Prismaflex 7.XX US, Product Code 115269 Intended Use: The Prismaflex Control Unit is intended for: " Continuous Renal Replacement Therapy (CRRT) for patients weighing 20 kilograms or more with acute renal failure and/or fluid overload. " Therapeutic Plasma Exchange (TPE) therapy for patients weighing 20 kilograms or more with diseases where removal of plasma components is indicated. " Continuous
| Date | Apr 24, 2018 |
| Status | Terminated |
| Reason | Baxter Healthcare will be installing new firmware on all Prismaflex control units to address the potential for a small number of these units to exhibit a failure mode with the pump module electronics. The failure mode may result in a Voltage Out of Range malfunction alarm, which causes the device to enter a safe state and become inoperable until it is serviced. Baxter will be releasing new firmware that will prevent the malfunction from occurring. |
| Root cause | Software design |
| Action | The firm, Baxter, sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated 4/24/2018 to its customers. The letter explained the reason for the recall and provided the following direction: "Operators may continue to safely use Prismaflex control units that have not exhibited the Voltage Out of Range malfunction alarm. A local Baxter service representative will contact your facility to determine the correction plan and schedule the firmware upgrade. Your facility will be receiving this firmware upgrade from Baxter at no charge. f you purchased this product directly from Baxter, complete the |
| Quantity | 557 units |
| Distribution | Worldwide distribution: United States (including Puerto Rico), and countries of: Canada, Australia, New Zealand, China, Bangladesh, Japan, Malaysia, Myanmar, Sri Lanka, India, Singapore, Vietnam, Hong Kong, Korea, Taiwan, Indonesia, Bruni, Philippines, Thailand, Argentina, Chile, Costa Rica, Dominic |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K131516 | PRISMAFLEX SYSTEM 7.10 Gambro Renal Products, Inc., Jan 3, 2014 |