BEUDAMED
    FDA Recall Terminated

    Baxter Amia Automated PD systems are used in the treatment of adult renal failure patients to perform automated peritoneal dialysis.

    Recall: Z-0932-2015 · Initiated April 24, 2014

    Recall

    Recall Number
    Z-0932-2015
    Event Number
    69586
    Firm
    Baxter Healthcare Corp.
    FEI Number
    1417572
    Product Code
    FKX
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    April 24, 2014
    Posted
    January 7, 2015
    Terminated
    July 21, 2017
    Address
    1 Baxter Pkwy, Deerfield, IL, 60015-4625

    Description

    Baxter Amia Automated PD systems are used in the treatment of adult renal failure patients to perform automated peritoneal dialysis.

    Reason

    System error 01779 is produced when the battery cannot be charged due to specific voltage differences between the battery and the charger.

    Action

    Baxter sent an IMPORTANT PRODUCT INFORMATION letter dated April 24, 2014 to all affected customers. The peritoneal dialysis provider consignees were instructed to: 1) complete the enclosed customer reply form and return it to Baxter; and, 2) contact Baxter Technical Services at 800-553-6898 should a System Event 01179 occur. Baxter Technical Services is available 24 hours a day, 7 days a week. Clinical questions can be directed to Baxter's Renal Clinical Helpline at 888-736-2543, option 2 (Monday - Friday, 8:00 AM - 5:00 PM CT). General questions regarding the Import Product Information letter can be direct to The Center for One Baxter at 800-422-9837 (Monday - Friday, 8:00 AM - 5:00 PM CT). For questions regarding this recall call 800-422-9837.

    Distribution

    Nationwide Distribution including GA, MA, NC, NY, PA, and WA.

    Quantity

    55 units