HomeChoice PRO Automated Peritoneal Dialysis Systems; Manufactured for Baxter Healthcare Corporation, Deerfield, IL 6001
FDA device recall Z-0397-05 · posted 2005-01-15 · Terminated
Recall details
- Recalling firm
- Baxter Healthcare Renal Div
- Reason for recall
- 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.
- Action taken
- 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 break all peel-seals prior to use. Patients will receive a new Pro-Card when their machine is exchanged, and the exchange will be documented. The HomeChoice Pro software will be updated to correct the software anomaly, validated and installed on the HomeChoice Pro machines.
- Root cause
- Other
- Status
- Terminated
- Product code
- FKX
- Quantity affected
- 165 units
- Distribution
- Those HomeChoice units in Denmark and Sweden only, where the Physioneal Clear-Flex products are approved for use.
- Date initiated
- 2004-12-23
- Date posted
- 2005-01-15
- Date terminated
- 2007-12-11
- Location
- Park, IL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HOMECHOICE PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM, MODELS 5C8310, 5C8302, 5C4471, 5C4469 (K012988) | Baxter Healthcare Corp | 2001-12-05 |