BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE CYCLER-REFURBISHED

    MDR report key: 1061054 · Received June 12, 2008

    Report

    Report Number
    1423500-2008-00485
    Event Type
    Malfunction
    Date Received
    June 12, 2008
    Date of Event
    December 11, 2007
    Report Date
    May 28, 2008
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FKX
    PMA / PMN Number
    K012988
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). ADDITIONAL 510(K) NUMBER: K923065. DEVICE RECEIVED FOR EVALUATION. THREE SIMULATED PATIENT THERAPIES WERE PERFORMED USING THE PATIENT'S THERAPY SETTINGS. DURING THESE THERAPIES, NO PROBLEMS WERE ENCOUNTERED. THE DEVICE WAS THEN TESTED FOR VOLUMETRIC ACCURACY. THIS TEST WAS PERFORMED AND THE FLUID VOLUME DELIVERED TO AND REMOVED FROM THE SIMULATED PATIENT FOR EACH EXCHANGE AND WAS WITHIN DESIGN. SOFTWARE WAS THEN USED TO MONITOR THE DEVICES PNEUMATIC SYSTEM. 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 FOR THIS PARTICULAR HOMECHOICE DEVICE. THE EVALUATION DID NOT CONFIRM ANY FAILURE OR MALFUNCTION OF THE DEVICE THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED DIFFICULTY. THE PROBABLE CAUSE OF THIS OVERFILL WAS DETERMINED TO BE: CATHETER ISSUES. DEVICE HAS BEEN SENT FOR SERVICING.

    Description of Event or Problem · 1

    DURING EVALUATION OF THE RETURNED DEVICE, AN OVERFILL SITUATION WAS DISCOVERED. THE HOME PATIENT (HP) HAD A DRAIN VOLUME OF 4499 DURING INITIAL DRAIN OF THE THERAPY STARTED ON (B) (6) 2007. THE PROGRAMMED FILL VOLUME FOR THIS HP IS 2500 ML. A FOLLOW-UP WITH THE NURSE (RN) REVEALED THE HP HAD BEEN HAVING PROBLEMS DRAINING DUE TO CATHETER ISSUES AND IS CURRENTLY NOT ON PERITONEAL DIALYSIS DUE TO THOSE CATHETER ISSUES. THE RN DID NOT KNOW ANY ADDITIONAL DETAILS REGARDING THE INCIDENT. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS ASSOCIATED WITH THE INCIDENT PER THE RN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1