BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE CYCLER-REFURBISHED

    MDR report key: 1033036 · Received April 22, 2008

    Report

    Report Number
    1423500-2008-00270
    Event Type
    Malfunction
    Date Received
    April 22, 2008
    Date of Event
    December 25, 2007
    Report Date
    April 9, 2008
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FKX
    PMA / PMN Number
    K012988
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: DURING REVIEW OF THE EVENT LOG, A POSSIBLE OVERFILL WAS IDENTIFIED OCCURRING IN LATE 2007 DURING THE INITIAL DRAIN. THE PT DRAINED 282ML AFTER A FILL VOLUME OF 100ML. DURING BAXTER'S INVESTIGATION OF THE DEVICE, SIMULATED THERAPIES WERE PERFORMED USING THE PT'S THERAPY SETTINGS. DURING THESE THERAPIES, NO PROBLEMS WERE ENCOUNTERED. THE DEVICE WAS THEN TESTED FOR VOLUMETRIC ACCURACY. THE FLUID VOLUME DELIVERED TO AND REMOVED FROM THE SIMULATED PT FOR EACH EXCHANGE WAS WITHIN DESIGN SPECIFICATIONS. SOFTWARE WAS THEN USED TO MONITOR THE DEVICE'S PNEUMATIC SYSTEM. NO PROBLEMS WERE REVEALED DURING THIS INSPECTION 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. REVIEW OF THE THERAPY LOGS DID NOT REVEAL ANY EVENTS OF BYPASSING ALARMS AND NO FAILURE MODES WERE IDENTIFIED. THE EVALUATION DID NOT CONFIRM ANY FAILURE OR MALFUNCTION OF THE DEVICE THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE POSSIBLE OVERFILL.

    Description of Event or Problem · 1

    DURING EVAL OF THE CUSTOMER'S HOMECHOICE DEVICE, A BAXTER TECHNICIAN IDENTIFIED A I POTENTIAL OVERFILL SITUATION. DURING THE INITIAL DRAIN OF THERAPY IN LATE 2007, THE CUSTOMER DRAINED 282ML AFTER A LAST FILL VOLUME OF 100ML DURING THE PREVIOUS THERAPY. NO FURTHER INFO REGARDING THIS EVENT OR THE STATUS OF THE PT COULD BE OBTAINED DESPITE MULTIPLE ATTEMPTS BY BAXTER. NO PT INJURY WAS REPORTED DURING THE INITIAL CONTACT.

    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