BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE

    MDR report key: 2767325 · Received October 1, 2012

    Report

    Report Number
    1416980-2012-01231
    Event Type
    Malfunction
    Date Received
    October 1, 2012
    Date of Event
    September 12, 2012
    Report Date
    September 12, 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). CONTINUITY VERIFICATION WAS PERFORMED ON THE ORIGINAL FUSES AND THEY WERE VISIBLY BLOWN. CHECKED FOR INFINITE RESISTANCE READING FROM GROUND TO EACH ALTERNATING CURRENT (AC) INPUT TERMINAL AND THE READINGS WERE ERRANTLY AT 1.92 MEGAOHMS AND 1.72 MEGAOHMS AND REMAINED AT THE READING AFTER THE POWER ENTRY MODULE (PEM) WAS DISCONNECTED, INDICATING A MALFUNCTIONING PEM. INSTALLED TEST ARTICLE PEM AND GROUND TO EACH AC INPUT TERMINAL SHOWED INFINITE RESISTANCE. VOLTAGE VERIFICATION WAS PERFORMED ON THE DIGITAL PRINTED CIRCUIT BOARD (PCB) (TP2, TP4, TP6, AND TP7 AND LITHIUM BATTERY) AND VOLTAGES WERE FOUND TO BE WITHIN SPECIFICATION. DUE TO THE BLOWN PEM FUSES THE UNIT WAS UNABLE TO RECEIVE POWER. ASSIGNABLE CAUSE FOR THE RITE FAILURE OF EARTH LEAKAGE: MALFUNCTIONING POWER ENTRY MODULE. SCRAP POWER ENTRY MODULE. DEVICE WAS SENT TO SERVICING.

    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 SPEC: EARTH LC SINGLE FAULT NORM MEASUREMENT 1354.6 MICROAMPS; EARTH LC SINGLE FAULT REV MEASUREMENT 1537.7 MICROAMPS (LOW LIMIT 4.0, HIGH LIMIT 500.0). 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