BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE

    MDR report key: 2872661 · Received December 13, 2012

    Report

    Report Number
    1416980-2012-07269
    Event Type
    Malfunction
    Date Received
    December 13, 2012
    Date of Event
    November 21, 2012
    Report Date
    November 21, 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 RETURN INSTRUMENT TEST/EVALUATION (RITE) EARTH LEAKAGE CURRENT TEST. THE DEVICE WAS EVALUATED BY THE PRODUCT ANALYSIS LAB (PAL) AND THE PROBLEM WAS NEITHER CONFIRMED NOR DUPLICATED. THE DEVICE WAS FOUND TO BE INFESTED WITH INSECTS. ASSIGNABLE CAUSE FOR RITE ELECTRICAL FAILED EARTH LEAKAGE CURRENT TESTS IS UNDETERMINED. PAL DID NOT CONFIRM THE FAILURE OR MALFUNCTION, HOWEVER CORROSION / CONTAMINATION MOST LIKELY CONTRIBUTED TO THE RITE EARTH LEAKAGE PROBLEM. PRODUCT IS IDENTIFIED FOR SCRAP.

    Description of Event or Problem · 1

    DURING EVALUATION OF A RETURNED HOMECHOICE (HC) DEVICE, A BAXTER TECHNICIAN DETERMINED THE HC MACHINE FAILED THE RETURNED INSTRUMENT TEST AND EVALUATION (RITE) TESTING DUE TO RITE - EARTH LEAKAGE CURRENT FAILED PERFORMANCE SPEC: EARTH LC NORMAL 1782.5 MICROAMPS, LC REVERSE 2880.6 MICROAMPS (RANGE 4.0 - 300.0 MICROAMPS); LC SINGLE FAULT NORMAL 4589.6 MICROAMPS, LC SINGLE FAULT REVERSE 4525.3 MICROAMPS (RANGE 4.0 - 500.0 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