BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE

    MDR report key: 3015832 · Received March 21, 2013

    Report

    Report Number
    1416980-2013-06881
    Event Type
    Malfunction
    Date Received
    March 21, 2013
    Date of Event
    March 15, 2013
    Report Date
    March 15, 2013
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING THE EVALUATION OF A RETURNED HOMECHOICE (HC) DEVICE, A BAXTER TECHNICIAN DETERMINED THE HC MACHINE FAILED THE RETURN INSTRUMENT TEST/EVALUATION (RITE) GROUND BOND FAILURE TEST. THE PRODUCT ANALYSIS LAB (PAL) EVALUATED THE DEVICE. AN EXTERNAL AND INTERNAL INSPECTION WERE PERFORMED AND NO PROBLEMS WERE FOUND. A CONTINUITY TEST BETWEEN THE POWER ENTRY MODULE (PEM) GROUND AND THE DOOR POST WAS PERFORMED AND THE RESISTANCE DECREASED WHEN THE PEM/GROUND STUD WIRE WAS AGITATED. THE POORLY SEATED PEM/GROUND STUD WIRE CAUSED A POOR CONNECTION BETWEEN THE PEM GROUND AND DOOR POST RESULTING IN THE GROUND BOND FAILURE. THE CAUSE FOR THE RITE FAILURE OF GROUND BOND FAILURE WAS DETERMINED TO BE A POORLY SEATED PEM/GROUND STUD WIRE. THE POWER MODULE WIRING HARNESS WAS SCRAPPED AND THE DEVICE WAS SENT TO SERVICE.

    Description of Event or Problem · 1

    DURING THE EVALUATION OF A RETURNED HOMECHOICE (HC) DEVICE, A BAXTER TECHNICIAN DETERMINED THE HC MACHINE FAILED THE GROUND BOND TEST, INDICATING A HIGH RESISTANCE VALUE BETWEEN THE HC AND THE GROUND BOND ON THE POWER SUPPLY. THE RITE TEST FAILURE WAS FOUND BY SERVICE PERSONNEL DURING EVALUATION AND NO PATIENT WAS INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    118500 HOMECHOICE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1