BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PD CYCLER 110 VOLT HOMECHOICE AUTOMATED

    MDR report key: 1082185 · Received July 25, 2008

    Report

    Report Number
    1423500-2008-00689
    Event Type
    Malfunction
    Date Received
    July 25, 2008
    Date of Event
    February 24, 2008
    Report Date
    July 9, 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

    EVAL RESULTS: THE HOMECHOICE MACHINE WAS RECEIVED AND EVALUATED. 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 VOLUMETRIC ACCURACY. THIS TEST WAS PERFORMED AND THE FLUID VOLUME DELIVERED TO AND REMOVED FROM THE SIMULATED PT FOR EACH EXCHANGE AND WAS WITHIN DESIGN SPECS. 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 OVERFILL DISCOVERED DURING EVAL. BASED ON A REVIEW OF ALL AVAILABLE INFO, THE PROBABLE CAUSE OF THIS OVERFILL WAS DETERMINED TO BE INSUFFICIENT DRAIN DUE TO MULTIPLE CYCLES THAT ADVANCED TO FILL WHEN THERE WAS A SLOW OR FLOW CONDITION DETECTED ABOVE THE MINIMUM DRAIN VOLUME THRESHOLD. THE DEVICE WILL BE ROUTED TO THE SERVICE AREA.

    Description of Event or Problem · 1

    DURING EVAL OF A RETURNED HOMECHOICE MACHINE, AN OVERFILL WAS IDENTIFIED. IN THE THERAPY SESSION STARTED IN 2008, DRAIN 3, THE HOME PT'S ULTRAFILTRATION (UF) READING WAS 980ML. THIS UF INDICATES THAT THE HOME PT (HP) DRAINED 980 ML MORE THAN THE PROGRAMMED FILL VOLUME OF 2400 ML FOR A TOTAL DRAIN OF 3380 ML. DURING F/U THE HP'S NURSE STATED THAT THE HP REPORTED TO HER THE MACHINE WAS "NOT DRAINING HIM FULLY" BUT SHE WAS NOT AWARE OF AN OVERFILL. THE MINIMUM DRAIN VOLUME PERCENTAGE WAS EXPLAINED TO THE NURSE AND SHE VOICED UNDERSTANDING. THE NURSE INFORMED THERE WAS NO PT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH OVERFILL FOR THIS PT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1