BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE

    MDR report key: 2635967 · Received June 29, 2012

    Report

    Report Number
    1423500-2012-13421
    Event Type
    Malfunction
    Date Received
    June 29, 2012
    Date of Event
    June 28, 2012
    Report Date
    June 28, 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 GROUND BOND VERIFICATION, MEASUREMENT: 0.101 OHM (SPECIFICATIONS ARE LOW LIMIT: 0.001 OHM, HIGH LIMIT: 0.100 OHM). PERFORMED CONTINUITY TEST BETWEEN POWER ENTRY MODULE (PEM) GROUND AND DOOR POST AND RESISTANCE WENT FROM 0.113 OHM TO 0.003 OHM WHEN THE PEM/GROUND STUD WIRE WAS AGITATED. ASSIGNABLE CAUSE FOR THE RITE FAILURE OF GROUND BOND FAILURE WAS DETERMINED TO BE CAUSED BY A POORLY SEATED PEM/GROUND STUD WIRE. SCRAP PEM/GROUND STUD WIRE. THE DEVICE WAS SENT FOR 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 - GROUND BOND FAILED PERFORMANCE SPEC: MEASUREMENT WAS 0.101 OHM (SPECIFICATIONS ARE LOW LIMIT: 0.001 OHM, HIGH LIMIT: 0.100 OHM). 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