BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PD CYCLER 110 VOLT HOME CHOICEPRO AUTOMATED

    MDR report key: 1014060 · Received March 13, 2008

    Report

    Report Number
    1423500-2008-00151
    Event Type
    Malfunction
    Date Received
    March 13, 2008
    Date of Event
    January 7, 2008
    Report Date
    February 12, 2008
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THREE SIMULATED THERAPIES WERE PERFORMED USING THE PT'S THERAPY SETTINGS. DURING THESE THERAPIES, NO PROBLEMS WERE ENCOUNTERED. THE DEVICE WAS TESTED FOR VOLUMETRIC ACCURACY, AND THE FLUID VOLUME DELIVERED TO AND REMOVED FROM THE SIMULATED PT FOR EACH EXCHANGE WAS WITHIN DESIGN SPECS. THE DEVICE'S PNEUMATIC SYSTEM WAS MONITORED AND NO PROBLEMS WERE REVEALED, AND ALL PRESSURES WERE CORRECT AND STABLE. THE COVER WAS OPENED AND AN INTERNAL INSPECTION WAS PERFORMED; NO PROBLEMS WERE REVEALED AND ALL CONNECTIONS WERE CORRECT AND SECURE. BASED ON A REVIEW OF ALL AVAIL THERAPY, ALARM AND EVENT LOG DATA, COMBINED WITH AVAIL DECISION TREE INFO, THE EVAL DETERMINED THE MOST PROBABLE CAUSE OF THE IDENTIFIED OVERFILL SITUATION TO BE MULTIPLE CYCLES ADVANCE TO FILL WHEN SLOW/NO FLOW OCCURRED ABOVE THE MINIMUM DRAIN VOLUME THRESHOLD. THE EVAL DID NOT CONFIRM ANY FAILURE OR MALFUNCTION OF THE DEVICE THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE IDENTIFIED OVERFILL SITUATION.

    Description of Event or Problem · 1

    DURING THE DEVICE EVAL, AN OVERFILL SITUATION WAS IDENTIFIED. DURING THE THERAPY STARTED IN EARLY 2008, THE CYCLE BY CYCLE ULTRAFILTRATION (UF) LOG REVEALED A POSITIVE UF OF 962 ML DURING CYCLE 5. THIS INDICATED THE HOME PT DRAINED A VOLUME OF 962 ML ABOVE THE PROGRAMMED FILL VOLUME OF 2000 ML. DURING THE PREVIOUS CYCLE OF THIS THERAPY, THE HOME PT HAD A NEGATIVE ULTRAFILTRATION, INDICATING THE HOME PT WAS FILLED WITH MORE SOLUTION THAN WAS DRAINED OUT. HOWEVER, DURING THIS CYCLE, THE DRAIN VOLUME WAS GREATER THAN THE PROGRAMMED MINIMUM DRAIN VOLUME PERCENTAGE, ALLOWING THERAPY TO ADVANCE. PER THE DEVICE EVAL, THE PROBABLE CAUSE OF THE IDENTIFIED OVERFILL SITUATION WAS MULTIPLE CYCLES ADVANCE TO FILL WHEN A SLOW/NO FLOW OCCURRED ABOVE THE MINIMUM DRAIN VOLUME THRESHOLD. F/U WAS MADE WITH THE HOME PT'S NURSE REGARDING THE IDENTIFIED OVERFILL SITUATION (ULTRAFILTRATION VALUE) FROM THE EVAL. THE NURSE INDICATED THE CAUSE OF THESE SITUATIONS WOULD BE THE HOME PT'S DIFFICULTY DRAINING, AS THEY OFTEN HAD PROBLEMS DRAINING BECAUSE OF THE NATURE OF THEIR PD THERAPY (HIGH TRANSPORTER WHO ABSORBED QUICKLY). THIS WRITER EXPLAINED THE IDENTIFIED CAUSE FROM THE EVAL AGREED WITH THE CAUSE IDENTIFIED BY THE NURSE (MULTIPLE CYCLES ADVANCE TO FILL WHEN SLOW/NO FLOW OCCURRED ABOVE THE MINIMUM DRAIN VOLUME THRESHOLD). ADD'L DETAILS PER THE OVERFILL CALL SCRIPT WERE UNK BY THE NURSE. THE HOME PT DID NOT REPORT ANY PT SYMPTOMS ASSOCIATED WITH THE IDENTIFIED OVERFILLS. THE NURSE STATED THERE WAS NO PT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THE IDENTIFIED OVERFILL SITUATIONS. NO ADJUSTMENTS NEEDED TO BE MADE TO THE HOME PT'S PROGRAMMING OR THERAPY AS THEY ARE NO LONGER PERFORMING PD THERAPY. THE NURSE ALSO INDICATED THE SWITCH OF THE HOME PT FROM PD TO HEMODIALYSIS WAS NOT RELATED TO THE QUALITY OF FUNCTION OF THE PD PRODUCTS, BUT INSTEAD, TO THE HOME PT'S PHYSIOLOGY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PD CYCLER 110 VOLT HOME CHOICEPRO AUTOMATED 78FKX FKX BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1