BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE

    MDR report key: 2830188 · Received November 13, 2012

    Report

    Report Number
    1416980-2012-04947
    Event Type
    Malfunction
    Date Received
    November 13, 2012
    Date of Event
    October 26, 2012
    Report Date
    October 26, 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). EVALUATION SUMMARY: THE DEVICE PASSED THE HC RETURN INSTRUMENT TEST/EVALUATION (RITE) ELECTRICAL TEST BUT FAILED RITE FUNCTIONAL TEST DUE TO FAILED TRANSFERRED VOLUME COMPARISON. THE ASSIGNABLE CAUSE FOR THE RITE FAILURE OF FAILED TRANSFERRED VOLUME COMPARISON WAS UNDETERMINED.

    Description of Event or Problem · 1

    DURING EVALUATION OF A RETURNED HOMECHOICE (HC) DEVICE, A BAXTER TECHNICIAN DETERMINED THE HC MACHINE FAILED RITE (RETURNED INSTRUMENT TEST/EVALUATION) TESTING DUE TO A(N): FAILED TRANSFERRED VOLUME COMPARISON. FILL 1 MEASUREMENT WAS 836.4ML, DRAIN1 MEASUREMENT WAS 835.5ML, FILL 2 MEASUREMENT WAS 847.7ML, DRAIN 2 MEASUREMENT WAS 847.2ML (ALLOWABLE RITE RANGE 774ML - 821ML) AND LAST FILL MEASUREMENT WAS 369.2ML (ALLOWABLE RITE RANGE 330ML - 365ML). 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