BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE CYCLER -REFURBISHED

    MDR report key: 1057155 · Received June 5, 2008

    Report

    Report Number
    1423500-2008-00455
    Event Type
    Malfunction
    Date Received
    June 5, 2008
    Date of Event
    January 10, 2008
    Report Date
    May 16, 2008
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FKX
    PMA / PMN Number
    K012988
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL 510(K) NUMBER: K923065. EVALUATION SUMMARY: THE EVALUATION DID NOT IDENTIFY ANY DEVICE FAILURE OR MALFUNCTION THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE OVERFILL IDENTIFIED DURING EVALUATION. BASED ON A REVIEW OF ALL AVAILABLE DEVICE LOG DATA, IT WAS DETERMINED THAT THE MOST PROBABLE CAUSE OF THE OVERFILL WAS INSUFFICIENT DRAIN/FALSE EMPTY DETECT AND USE ERROR, INAPPROPRIATELY SET TOTAL ULTRAFILTRATION (UF) TOO LOW. THE DEVICE WILL BE FORWARDED TO THE SERVICE AREA.

    Description of Event or Problem · 1

    DURING EVALUATION OF A RETURNED HOMECHOICE DEVICE, A BAXTER TECHNICIAN IDENTIFIED A POTENTIAL OVERFILL SITUATION. DURING DRAIN 4 OF THERAPY IN 2008, THE PATIENT DRAINED 3348ML FOLLOWING A FILL VOLUME OF 2000ML. NO FURTHER INFORMATION REGARDING THIS EVENT COULD BE OBTAINED DESPITE MULTIPLE ATTEMPTS BY BAXTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE CYCLER -REFURBISHED 78FKX FKX BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1