BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE

    MDR report key: 2449375 · Received February 14, 2012

    Report

    Report Number
    1423500-2012-03465
    Event Type
    Malfunction
    Date Received
    February 14, 2012
    Date of Event
    January 24, 2012
    Report Date
    January 24, 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 TEST. THE DEVICE WAS RECEIVED OPERATIVE AND IN GOOD CONDITION. EXTERNAL/INTERNAL INSPECTION WAS PERFORMED AND PASSED. DEVICE POWERED UP PROPERLY AND NO ERRORS OCCURRED. PERFORMED CONTINUITY TEST BETWEEN POWER ENTRY MODULE (PEM) GROUND AND DOOR POST AND RESISTANCE WENT FROM 0.145 TO 0.011 OHMS 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. 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. DEVICE WAS SENT TO SERVICING.

    Description of Event or Problem · 1

    DURING 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. 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