BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE CYCLER-REFURBISHED

    MDR report key: 1051947 · Received May 22, 2008

    Report

    Report Number
    1423500-2008-00398
    Event Type
    Malfunction
    Date Received
    May 22, 2008
    Date of Event
    March 8, 2008
    Report Date
    May 5, 2008
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FKX
    PMA / PMN Number
    K012988
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE EVALUATION DID NOT CONFIRM ANY FAILURE OR MALFUNCTION OF THE DEVICE THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE OVERFILL SITUATION IDENTIFIED DURING EVAL. BASED ON A REVIEW OF ALL THE LOG DATA COMBINED WITH AVAILABLE DECISION TREE INFO, THE PROBABLE CAUSE OF THIS OVERFILL WAS DETERMINED TO BE INSUFFICIENT DRAIN/MULTIPLE CYCLES ADVANCED TO FILL WHEN SLOW/NO FLOW CONDITION OCCURRED ABOVE THE MINIMUM DRAIN VOLUME THRESHOLD AND/OR INSUFFICIENT DRAIN/FALSE EMPTY DETECT AND LAST MANUAL DRAIN NOT USED. THE DEVICE WILL BE ROUTED 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 THE INITIAL DRAIN OF THERAPY IN 2008, THE PT HAD AN ULTRAFILTRATION OF 453ML FOLLOWING A LAST FILL OF 0ML. THE HOME PT'S NURSE COULD PROVIDE NO FURTHER INFO RELATED TO THIS EVENT, BUT STATED THAT THE PT IS SUCCESSFULLY CONTINUING THERAPY. THERE WAS NO PT INJURY OR MEDICAL INTERVENTION.

    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