BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE CYCLER-REFURBISHED

    MDR report key: 1001232 · Received February 22, 2008

    Report

    Report Number
    1423500-2008-00101
    Event Type
    Malfunction
    Date Received
    February 22, 2008
    Date of Event
    October 3, 2007
    Report Date
    January 24, 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

    THREE SIMULATED PT THERAPIES WERE PERFORMED USING THE PTS 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 PT FOR EACH EXCHANGE WAS WITHIN DESIGN SPECIFICATIONS. THE CRT 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. PER THE EVALUATION, IT WAS DETERMINED THE MOST PROBABLE CAUSE OF THE IDENTIFIED OVERFILL SITUATION WAS INSUFFICIENT DRAIN, MULTIPLE CYCLES ADVANCE TO FILL WHEN SLOW / NO FLOW OCCURRED ABOVE THE MINIMUM DRAIN VOLUME THRESHOLD.

    Description of Event or Problem · 1

    DURING EVALUATION OF THE DEVICE IN THE CROSS REFERENCED COMPLAINT, AN OVERFILL SITUATION WAS IDENTIFIED. AT THE TIME OF THE INITIAL REPORT, THE HOME PT REPORTED CRAMPING/DISCOMFORT DURING DWELL 3 OF THERAPY. THE EVALUATION IDENTIFIED AN OVERFILL SITUATION IN DRAIN 3. THE PROGRAMMED THERAPY PARAMETERS ARE AS FOLLOWS: THERAPY = CCPD/IPD, THERAPY VOLUME = 8000ML, THERAPY TIME = 8:00, FILL VOLUME = 2000ML, LAST FILL VOLUME=0ML, INITIAL DRAIN ALARM=0, CYCLES=4, CALCULATED DWELL TIME = 1:34, MINIMUM DRAIN VOLUME PERCENTAGE=85%, LAST MANUAL DRAIN=NO. DURING DRAIN 3 OF THERAPY THE HOME PT DRAINED A VOLUME OF 3090ML. DURING DRAIN 2 OF THERAPY (PREVIOUS DRAIN TO IDENTIFIED OVERFILL), THE HOME PT HAD A NEGATIVE ULTRAFILTRATION. THE NEGATIVE ULTRAFILTRATION INDICATES THERE WAS SOLUTION LEFT IN THE HOME PT. THE DRAIN VOLUME WAS GREATER THAN THE PROGRAMMED MINIMUM DRAIN PERCENTAGE OF 85%, ALLOWING THE SYSTEM TO ADVANCE TO THE NEXT CYCLE. THERE WERE NO BYPASSES AND THERE WERE NO MANUAL DRAINS. THERE WAS NO PT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. FOLLOW-UP WITH THE HOME PT'S NURSE DID NOT REVEAL FURTHER DETAILS OF THE REPORT, HOWEVER, THE NURSE INDICATED THE HOME PT IS DOING WELL.

    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