BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE

    MDR report key: 3142431 · Received June 3, 2013

    Report

    Report Number
    1416980-2013-14068
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Date of Event
    May 16, 2013
    Report Date
    May 16, 2013
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE RITE FAILURE OF THERAPY MONITORED VOLUME FAILED WAS NOT CONFIRMED IN THE DEVICE LOGS BUT CONFIRMED IN THE SAMPLE EVALUATION. THE DEVICE PASSED THE HC RETURN INSTRUMENT TEST/EVALUATION (RITE) ELECTRICAL TEST BUT FAILED RITE FUNCTIONAL TEST DUE TO THERAPY MONITORED VOLUME FAILED. THE CAUSE FOR THE RITE FAILURE OF FAILED VOLUME TRANSFERRED COMPARISON WAS UNDETERMINED.

    Description of Event or Problem · 1

    DURING THE 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
    244957 HOMECHOICE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1