BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE

    MDR report key: 3132886 · Received May 29, 2013

    Report

    Report Number
    1416980-2013-13494
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    May 9, 2013
    Report Date
    May 9, 2013
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION: THE DEVICE WAS TESTED AND PASSED THE HOMECHOICE RETURN INSTRUMENT TEST EVALUATION (RITE) ELECTRICAL TEST, BUT FAILED THE RITE FUNCTIONAL TEST DUE TO VOLUMETRIC ACCURACY OUT OF LIMITS. (B)(4). THE DEVICE WAS DETERMINED TO NOT MEET SPECIFICATIONS PER RITE TESTING. THE ASSIGNABLE CAUSE WAS DETERMINED TO BE DISINTEGRATED PISTON FOAM. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A FOLLOW-UP WILL BE SUBMITTED.

    Description of Event or Problem · 1

    DURING EVALUATION OF A RETURNED HOMECHOICE (HC) DEVICE, A BAXTER TECHNICIAN DETERMINED THE HC MACHINE FAILED FLUID VOLUME ACCURACY TESTING. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236481 HOMECHOICE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1