BEUDAMED
    FDA Recall Terminated

    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

    Recall: Z-0397-05 · Initiated December 23, 2004

    Recall

    Recall Number
    Z-0397-05
    Event Number
    30693
    Firm
    Baxter Healthcare Renal Div
    FEI Number
    3000210122
    Product Code
    FKX
    Status
    Terminated
    Root Cause
    Other
    Initiated
    December 23, 2004
    Posted
    January 15, 2005
    Terminated
    December 11, 2007
    Address
    1620 Waukegan Rd, Bldg R, Mc Gaw Park, IL, 60085-6730

    Description

    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

    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.

    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 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.

    Distribution

    Those HomeChoice units in Denmark and Sweden only, where the Physioneal Clear-Flex products are approved for use.

    Quantity

    165 units