BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE CYCLER-REFURBISHED

    MDR report key: 1073684 · Received July 3, 2008

    Report

    Report Number
    1423500-2008-00601
    Event Type
    Malfunction
    Date Received
    July 3, 2008
    Date of Event
    January 17, 2008
    Report Date
    June 18, 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). EVALUATION SUMMARY: THE HOMECHOICE MACHINE WAS REC'D AND EVALUATED. THREE STIMULATED 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 PATIENT FOR EACH EXCHANGE 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 THE 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 NO FLOW CONDITION DETECTED ABOVE THE MINIMUM DRAIN VOLUME THRESHOLD AND/OR INSUFFICIENT DRAIN DUE TO A FALSE EMPTY DETECT AT INITIAL DRAIN. THE DEVICE WILL BE ROUTED TO THE SERVICE AREA.

    Description of Event or Problem · 1

    DURING EVALUATION OF A RETURNED HOMECHOICE MACHINE, THE PRODUCT ANALYSIS LABORATORY (PAL) DISCOVERED ON OVERFILL. IN THE THERAPY SESSION STARTED ON (B) (6) 2008, DRAIN 2, THE HOME PT'S ULTRAFILTRATION (UF) READING WAS 940 ML. THIS UF INDICATES THAT THE HOME PATIENT (HP) DRAINED 940 ML MORE THAN THE PROGRAMMED FILL VOLUME OF 2000 ML FOR A TOTAL OF 2940 ML. PER THE HOME PATIENT'S NURSE, THERAPY HAS BEEN GOING WELL AND THERE WAS NO PT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH OVERFILL.

    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