Recall Z-1280-2018 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Baxter Healthcare Corporation
Prismaflex Control Unit. Dialyzer, high permeability with or without sealed dialysate system. 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.
| Date | Feb 15, 2017 |
| Status | Terminated |
| Reason | Firm has received reports of device operators failing to adhere to instructions for use pertaining to the safe unloading of disposable sets from the Prismaflex Control Unit. Additionally, for software versions 5.10 and 6.10, the programmed syringe size for the syringe pump may revert to safe default values unintentionally. |
| Root cause | Use error |
| Action | On February 15, 2017, the firm sent an Urgent Device Correction notification and response form to affected customers via USPS first class mail in order to update software versions of the Prismaflex Control Units. The update was intended to prevent user errors related to the safe unloading of disposable sets. On May 30, 2017, the firm issued an updated notification letter notifying the same customer base of the issue with the programmed syringe sizes. The software update deployed to correct the issue with the safe unloading of disposable sets was also deployed to correct the issue with the |
| Quantity | 3,440 units |
| Distribution | Worldwide Distribution - USA (nationwide) Distribution and to the countries of : Algeria, Armenia, Australia, Bahrain, Belarus, Belgium, Canada, China, Cyprus, Denmark, Egypt, France, Germany, Great Britain, Greece, Ireland, Italy, Albania, Bulgaria, Croatia, Czech Republic, Estonia, Hong Kong, Hun |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K110823 | PRISMAFLEX Gambro Renal Products, Inc., Jun 17, 2011 |