BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE

    MDR report key: 2547403 · Received April 25, 2012

    Report

    Report Number
    1423500-2012-09671
    Event Type
    Malfunction
    Date Received
    April 25, 2012
    Date of Event
    April 17, 2012
    Report Date
    April 17, 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). PERFORMED CONTINUITY TEST BETWEEN POWER ENTRY MODULE (PEM) GROUND AND DOOR POST AND RESISTANCE WENT FROM 0.112 TO 0.010 OHMS 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. 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 RETURNED INSTRUMENT TEST EVALUATION (RITE) FOR GROUND BOND VERIFICATION, WITH A MEASUREMENT OF 0.104 OHM. THE SPECIFICATIONS ARE 0.001 OHM - 0.100 OHM. THIS WAS A RITE TEST FAILURE, AND NO PATIENT WAS 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