BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 2840818 · Received November 20, 2012

    Report

    Report Number
    1416980-2012-05680
    Event Type
    Malfunction
    Date Received
    November 20, 2012
    Date of Event
    October 29, 2012
    Report Date
    October 29, 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) GROUND BOND FAILURE TEST: MEASUREMENT 0.104 OHM (SPECIFICATION (B)(4)). GROUND BOND TESTING WAS PERFORMED BY THE PRODUCT ANALYSIS LAB (PAL) WITH NO PROBLEM FOUND, THE GROUND BOND MEASURED 0.023 OHM. THE ASSIGNABLE CAUSE FOR THE RITE FAILED GROUND BOND TESTING WAS UNDETERMINED; PAL DID NOT CONFIRM OR DUPLICATE ANY FAILURE OR MALFUNCTION WHICH COULD CAUSE THE RITE PROBLEM. DEVICE WAS SENT TO SERVICE.

    Description of Event or Problem · 1

    THE PRODUCT ANALYSIS LABORATORY (PAL) DETERMINED THE HOMECHOICE (HC) MACHINE SYSTEM FAILED RETURNED INSTRUMENT TEST AND EVALUATION (RITE) TESTING DUE TO RITE- GROUND BOND FAILED PERFORMANCE SPEC: MEASUREMENT 0.104 OHM ((B)(4)). RITE TEST FAILURE, NO PATIENT INVOLVED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1