BEUDAMED
    FDA Enforcement Class II Terminated

    1) The HomeChoice automated peritoneal dialysis system. Dataplate located on the device is labeled in part: Baxter. 2) The HomeChoice PRO automated peritoneal dialysis system. Dataplate located on the device is labeled in part: Baxter. The HomeChoice/HomeChoice Pro Automated Personal Cycler peritoneal dialysis system is intended for automatic control of dialysate solution exchange in the treatment of pediatric and adult renal failure patients undergoing peritoneal dialysis.

    Recall: Z-2609-2016 · Reported August 31, 2016

    Enforcement

    Recall Number
    Z-2609-2016
    Event ID
    66606
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Baxter Healthcare Corp.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 31, 2016
    Initiation Date
    October 7, 2013
    Classification Date
    August 22, 2016
    Termination Date
    December 23, 2016
    Address
    1 Baxter Pkwy, Deerfield, IL, 60015-4625, United States

    Description

    1) The HomeChoice automated peritoneal dialysis system. Dataplate located on the device is labeled in part: Baxter. 2) The HomeChoice PRO automated peritoneal dialysis system. Dataplate located on the device is labeled in part: Baxter. The HomeChoice/HomeChoice Pro Automated Personal Cycler peritoneal dialysis system is intended for automatic control of dialysate solution exchange in the treatment of pediatric and adult renal failure patients undergoing peritoneal dialysis.

    Reason

    In systems with version 10.4 software Initial Drain logic, the device will attempt to drain the patient to empty at the beginning of therapy (initial drain). The operator can stop, but cannot bypass, the active Initial Drain. This is to mitigate against Unintended Increased Intraperitoneal Volume (IIVP). This can cause serious problems in patients with unrelated a co-morbid condition of ascites.

    Code Info

    *** 1) HomeChoice automated peritoneal dialysis system: Product Codes: 5C4471 and 5C4471R; Serial Numbers: All serial numbers; *** 2) HomeChoice Pro automated peritoneal dialysis system: Product Codes: 5C8310 and 5C8310R; Serial Numbers: All serial numbers

    Distribution

    Worldwide distribution. US nationwide including Puerto Rico; Australia, Canada, New Zealand, and Japan

    Quantity

    *** 1) Product Codes 5C4471 and 5C4471R: Approximately 48,600 units; *** 2) Product Codes 5C8310 and 5C8310R: Approxiamtely 16,990 units