BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PD CYCLER 110 VOLT HOME CHOICEPRO AUTOMATED

    MDR report key: 1071540 · Received July 3, 2008

    Report

    Report Number
    1423500-2008-00608
    Event Type
    Malfunction
    Date Received
    July 3, 2008
    Date of Event
    February 16, 2008
    Report Date
    June 9, 2008
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FKX
    PMA / PMN Number
    K012988
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). EVAL RESULTS: THE HOMECHOICE MACHINE WAS RECEIVED IN FAIR CONDITION 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 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 CORRECTIONS 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 MULTIPLE CYCLES THAT ADVANCED TO FILL WHEN THERE WAS A SLOW OR NO 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 ON (B) (6) 2008, DRAIN 3, THE HOME PT'S ULTRAFILTRATION (UF) READING WAS 641 ML. THE UF INDICATES THAT THE HOME PT (HP) DRAINED 641 ML MORE THAN THE PROGRAMMED FILL VOLUME OF 2000 ML, FOR A TOTAL DRAIN OF 2641 ML. PRODUCT SURVEILLANCE CONTACTED THE HP REGARDING THIS ISSUE. SHE DID NOT REMEMBER THE SPECIFIC DATES, BUT SHE DID HAVE PROBLEMS WITH FEELING TOO FULL AT TIME DURING THERAPY. SHE STATED THAT HER FINAL FILL VOLUME WAS LOWERED 500 ML AND THIS ALLEVIATED THE PROBLEM. THE MINIMUM DRAIN VOLUME PERCENTAGE WAS EXPLAINED TO THE PT AND SHE VOICED UNDERSTANDING. THERAPY IS NOW GOING WELL AND SHE HAS NOT HAD ANY MORE PROBLEMS. THERE WAS NO PT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS REPORT.

    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 56 YR