BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE

    MDR report key: 2945489 · Received February 6, 2013

    Report

    Report Number
    1416980-2013-03024
    Event Type
    Malfunction
    Date Received
    February 6, 2013
    Date of Event
    January 25, 2013
    Report Date
    January 25, 2013
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    SERVICE AND TESTING PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING EVALUATION OF A RETURNED HOMECHOICE (HC) DEVICE, A BAXTER TECHNICIAN DETERMINED THE HC MACHINE FAILED THE RETURN INSTRUMENT TEST/EVALUATION (RITE) EARTH LEAKAGE CURRENT TEST: EARTH LC NORMAL 56.2 MICROAMPS (4.0 - 300.0), EARTH LC REVERSE 793.0 MICROAMPS (4.0 - 300.0), EARTH LC SINGLE FAULT NORMAL 728.9 MICROAMPS (4.0 - 500.0), EARTH LC SINGLE FAULT REVERSE 808.1 MICROAMPS (4.0 - 500.0). THE DEVICE WAS EVALUATED BY THE PRODUCT ANALYSIS LAB (PAL) AND THE PROBLEM WAS NEITHER CONFIRMED NOR DUPLICATED. THE ASSIGNABLE CAUSE FOR THE RITE ELECTRICAL TEST FAILED EARTH LEAKAGE CURRENT TESTS WAS UNDETERMINED. DEVICE WAS SENT TO SERVICE.

    Description of Event or Problem · 1

    THE PRODUCT ANALYSIS LABORATORY (PAL) DETERMINED THE HOMECHOICE (HC) MACHINE SYSTEM FAILED RITE (RETURNED INSTRUMENT TEST/EVALUATION) TESTING DUE TO RITE - EARTH LEAKAGE CURRENT FAILED PERFORMANCE SPEC: EARTH LC NORMAL 56.2 MICROAMPS (4.0 - 300.0), EARTH LC REVERSE 793.0 MICROAMPS (4.0 - 300.0), EARTH LC SINGLE FAULT NORMAL 728.9 MICROAMPS (4.0 - 500.0), EARTH LC SINGLE FAULT REVERSE 808.1 MICROAMPS (4.0 - 500.0). RITE TEST FAILURE, NO PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50423 HOMECHOICE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1