BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE

    MDR report key: 2874020 · Received December 14, 2012

    Report

    Report Number
    1416980-2012-07362
    Event Type
    Malfunction
    Date Received
    December 14, 2012
    Date of Event
    September 8, 2011
    Report Date
    September 8, 2011
    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). EVALUATION SUMMARY: THE RITE (HOME CHOICE RETURN INSTRUMENT TEST/EVALUATION) ELECTRICAL TEST PASSED SPECIFICATIONS BUT THE RITE FUNCTIONAL TEST FAILED. THE ASSIGNABLE CAUSE OF THE FAILED GROUND BOND TEST WAS UNDETERMINED.

    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. THE GROUND BOND FAILED AT 0.127OHMS AND THE LIMITS WERE 0.001 - 0.100OHMS. THERE WAS NO PATIENT INVOLVEMENT.

    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