BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE CYCLER-REFURBISHED

    MDR report key: 1021866 · Received March 28, 2008

    Report

    Report Number
    1423500-2008-00195
    Event Type
    Malfunction
    Date Received
    March 28, 2008
    Date of Event
    January 14, 2008
    Report Date
    February 29, 2008
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FKX
    PMA / PMN Number
    K012988
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED HOMECHOICE MACHINE WAS EVALUATED BY THE PRODUCT ANALYSIS LAB. THREE SIMULATED PT THERAPIES WERE PERFORMED USING THE PT'S THERAPY SETTINGS. DURING THESE THERAPIES NO PROBLEMS WERE ENCOUNTERED. THE DEVICE WAS THEN TESTED FOR TEMPERATURE ACCURACY AND NO FLUID TEMPERATURES WERE RECORDED THAT WERE OUTSIDE THE SPECIFIED DELIVERY RANGE. THE DEVICE WAS THEN TESTED FOR VOLUMETRIC ACCURACY. THIS TEST WAS PERFORMED AND THE FLUID VOLUME DELIVERED TO AND REMOVED FROM THE SIMULATED PT FOR EACH EXCHANGE, AND THE MACHINE WAS WITHIN SPECIFICATIONS. THE DEVICE'S PNEUMATIC SYSTEM WAS TESTED, AND NO PROBLEMS WERE REVEALED AND ALL PRESSURES WERE CORRECT AND STABLE. THE COVER WAS OPENED AND AN INTERNAL INSPECTION PERFORMED, NO PROBLEMS WERE REVEALED DURING THIS INSPECTION AND ALL CONNECTIONS WERE CORRECT AND SECURE. A REVIEW OF THE DEVICE SERVICE HISTORY REVEALED NO PAST TRENDS. A REVIEW OF THE DEVICE'S CYCLE BY CYCLE ULTRAFILTRATION (UF) LOG REVEALED ONE POSSIBLE INSTANCE OF OVERFILL. PER THE LOG IN EARLY 2008, THE UF IN DRAIN CYCLE 1 WAS 856 ML, INDICATING A TOTAL DRAIN VOLUME OF 3056 ML. THE PROGRAMMED FILL VOLUME FOR THIS PT IS 2200ML. THE CYCLE BY CYCLE UF LOG DOES NOT CONTAIN SUFFICIENT DATA TO DETERMINE THE PROBABLE CAUSE. THE PAL DID NOT CONFIRM ANY FAILURE OR MALFUNCTION OF THE DEVICE THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED DIFFICULTY.

    Description of Event or Problem · 1

    DURING EVAL OF A RETURNED HOMECHOICE MACHINE, AN OVERFILL SITUATION WAS IDENTIFIED IN THE CYCLE BY CYCLE ULTRAFILTRATION (UF) LOG IN EARLY 2008, DRAIN CYCLE 1. PER THE LOG, THE PT'S UF READING WAS 856 ML INDICATING THE HOME PT (HP) DRAINED 856 ML MORE THAN THE PROGRAMMED FILL VOLUME OF 2200 ML. THIS INFO GIVES A TOTAL DRAIN VOLUME OF 3056 ML (2200 ML + 856 ML) WHICH IS GREATER THAN 1.3 TIMES THE LAST VOLUME INFUSED (2200ML). THE CYCLE BY CYCLE UF LOG DID NOT CONTAIN SUFFICIENT DATA TO DETERMINE THE PROBABLE CAUSE OF THE OVERFILL SITUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE CYCLER-REFURBISHED 78FKX FKX BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1