Recall Z-0397-05 ยท FKX System, Peritoneal, Automatic Delivery
Baxter Healthcare Renal Div
HomeChoice PRO Automated Peritoneal Dialysis Systems; Manufactured for Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A., Made in U.S.A.; catalog numbers 5C8310, 5C8310R, R5C8320, R5C8320R
| Date | Jan 15, 2005 (initiated Dec 23, 2004) |
| Status | Terminated |
| Reason | A software anomaly may allow concentrated solution to be infused into the patient when the HomeChoice unit is used with Physioneal Clear-Flex PD products. |
| Root cause | Other |
| Action | Baxter notified the Danish Ministry of Health of the problem with the HomeChoice Pro not prompting the patient when using the Physioneal Clear-Flex PD products on 12/23/04. The patients in Denmark and Sweden will be re-evaluate and re-train each patient as needed using enhanced training materials, which will include the importance of and the rationales for breaking the peel-seal on teh Physioneal ClearFlex prior to use and what to do if mis-infusion occurs. Larger, adhesive, colored stickers will be affixed to all applicable HomeChoice Pro machines to further remind patients of the need to |
| Quantity | 165 units |
| Distribution | Those HomeChoice units in Denmark and Sweden only, where the Physioneal Clear-Flex products are approved for use. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K012988 | HOMECHOICE PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM, MODELS 5C8310, 5C8302, 5C4471, 5C4469 Baxter Healthcare Corp, Dec 5, 2001 |