BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE CYCLER-REFURBISHED

    MDR report key: 1082140 · Received July 25, 2008

    Report

    Report Number
    1423500-2008-00693
    Event Type
    Malfunction
    Date Received
    July 25, 2008
    Date of Event
    April 15, 2008
    Report Date
    July 11, 2008
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). EVALUATION - THE HOMECHOICE MACHINE WAS RECEIVED AND EVALUATED. 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 SPECIFICATIONS. THE DEVICE'S PNEUMATIC SYSTEM WAS MONITORED AND NO PROBLEMS WERE REVEALED; ALL PRESSURES WERE CORRECT AND STABLE. THE COVER WAS OPENED AND AN INTERNAL INSPECTION WAS PERFORMED. NO PROBLEMS WERE ENCOUNTERED AND ALL CONNECTIONS WERE CORRECT AND SECURE. A REVIEW OF THE DEVICE'S SERVICE HISTORY REVEALED NO ISSUES RELATED TO OVERFILL. NO FAILURE OR MALFUNCTION OF THE DEVICE WAS OBSERVED THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED DIFFICULTY. BASED ON A REVIEW OF ALL AVAILABLE INFORMATION, THE PROBABLE CAUSE OF THIS OVERFILL WAS DETERMINED TO BE INSUFFICIENT DRAIN DUE TO FALSE EMPTY DETECT AND USER ERROR BECAUSE THE MINIMUM DRAIN VOLUME PERCENTAGE WAS INAPPROPRIATELY PROGRAMMED TOO LOW (75%) AND INSUFFICIENT DRAIN DUE TO MULTIPLE CYCLES THAT ADVANCED TO FILL WHEN A SLOW/NO FLOW CONDITION OCCURRED ABOVE THE MINIMUM DRAIN VOLUME THRESHOLD. THE DEVICE WILL BE ROUTED TO THE SERVICE AREA.

    Description of Event or Problem · 1

    DURING EVALUATION OF A RETURNED HOMECHOICE MACHINE, AN OVERFILL WAS IDENTIFIED. IN THE THERAPY SESSION STATED IN (B) (6) 2008, DRAIN 4, THE HOME PATIENT'S ULTRAFILTRATION (UF) READING WAS 1639 ML. THIS UF INDICATES THAT THE HOME PATIENT (HP) DRAINED 1639 ML MORE THAN THE PROGRAMMED FILL VOLUME OF 2500 ML FOR A TOTAL DRAIN OF 4139 ML. A FOLLOW UP CALL WAS PLACED TO THE HOME PATIENT'S NURSE REGARDING THIS ISSUE. THE NURSE RECENTLY SAW THIS PATIENT AND HE IS DOING WELL WITH THERAPY. HE DID NOT REPORT ANY ISSUES OF OVERFILL OR ANY PROBLEMS WITH THERAPY TO THE NURSE. SHE WAS INFORMED OF THE 75% MINIMUM DRAIN VOLUME PERCENTAGE AND SHE DID NOT KNOW WHY IT WOULD HAVE BEEN CHANGED IN THE PARAMETERS OF THE PATIENT'S HOMECHOICE MACHINE. SHE STATED THAT THE NEW MACHINE HE RECEIVED AFTER THE SWAP HAS THE DEFAULT MINIMUM DRAIN VOLUME PERCENTAGE OF 85%. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH OVERFILL FOR THIS PATIENT ACCORDING TO THE NURSE.

    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 63 YR