Recall Z-0153-06 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Baxter Healthcare Renal Div
Accura System for Blood Filtration, product codes 5M5660 and ACCURA01 (international); a hemofiltration system; Baxter Healthcare Corporation, Renal Division, McGaw Park, IL 60085, manufactured in Germany
| Date | Nov 16, 2005 (initiated Aug 29, 2005) |
| Status | Terminated |
| Reason | A software anomaly that occurs when the Reset Totals option is selected during CVVHD therapy with a diaylsate flow rate of less than 600 mL/hour, or CVVH therapy with a predilution flow rate of less than 600 mL/hour, causes balance alarms without an obvious cause. |
| Root cause | Other |
| Action | Baxter sent Urgent Device Correction letters dated 8/29/05 to all Accura device customers via first class mail. The letter informed the accounts of the balance alarms without an obvious cause as a result of a software anomaly that occurs when the Reset Totals option is selected during either CVVHD therapy with a diaylsate flow rate of less than 600 mL/hour, or CVVH therapy with a predilution flow rate of less than 600 mL/hour. To reduce the probability of a balance alarm occurring or reoccurring for this reason, the customers were instructed to not press the Reset Totals option when the dialys |
| Quantity | 255 units |
| Distribution | Nationwide, and internationally to China and Belgium |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K021615 | BAXTER ACCURA SYSTEM, MODEL 5M5660 Baxter Healthcare Corp, Nov 18, 2002 |