BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE

    MDR report key: 2671707 · Received July 26, 2012

    Report

    Report Number
    1423500-2012-15106
    Event Type
    Malfunction
    Date Received
    July 26, 2012
    Date of Event
    July 11, 2012
    Report Date
    July 11, 2012
    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 EARTH LEAKAGE CURRENT TEST. CHECKED FOR INFINITE RESISTANCE READING FROM GROUND TO EACH AC INPUT TERMINAL AT THE POWER ENTRY MODULE (PEM), FAULT WAS ISOLATED TO PEM. THE RITE LEAKAGE FAILURE WAS DETERMINED TO BE MALFUNCTIONING PEM. THE DEVICE WAS IDENTIFIED TO BE SCRAPPED.

    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 A RITE - EARTH LEAKAGE CURRENT FAILED PERFORMANCE SPECIFICATION. THE EARTH LC REVERSE MEASUREMENT WAS 474.2 MICROAMPS (SPECIFICATION: 4 MICROAMPS - 300 MICROAMPS). THE EARTH LC SINGLE FAULT REVERSE MEASUREMENT WAS 533.5 MICROAMPS (SPECIFICATION: 4 MICROAMPS - 500 MICROAMPS). RITE TEST FAILURE, NO PATIENT INVOLVED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1