BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE CYCLER-REFURBISHED

    MDR report key: 1081792 · Received July 18, 2008

    Report

    Report Number
    1423500-2008-00658
    Event Type
    Malfunction
    Date Received
    July 18, 2008
    Date of Event
    March 24, 2008
    Report Date
    July 8, 2008
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE EVAL DID NOT CONFIRM ANY FAILURE OR MALFUNCTION OF THE DEVICE THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THIS OVERFILL DISCOVERED DURING EVAL. BASED ON A REVIEW OF ALL AVAILABLE THERAPY LOG DATA, THE MOST PROBABLE CAUSE OF THE OVERFILL WAS DETERMINED TO BE INSUFFICIENT DRAIN, CAUSED BY THE TOTAL UF BEING PROGRAMMED TOO LOW (100MLS). THE DEVICE WILL BE ROUTED TO THE SVC AREA. AS A RESULT OF THIS INCIDENT, THE EVAL RESULTS WERE REVIEWED WITH THE DIALYSIS CENTER NURSE (RN). THE RN CONCURRED WITH BAXTER'S CONCLUSION THAT THE CAUSE OF THIS INCIDENT WAS RELATED TO THE TOTAL UF BEING PROGRAMMED TOO LOW AT 100MLS.

    Description of Event or Problem · 1

    DURING EVAL OF A RETURNED HOMECHOICE MACHINE, A POSSIBLE OVERFILL SITUATION WAS IDENTIFIED WHICH OCCURRED ON 3/24/08, DURING DRAIN CYCLE 4. THE PT'S ULTRAFILTRATION READING WAS 1246ML INDICATING THE HOME PT (HP) DRAINED 1246ML MORE THAN THEIR PROGRAMMED TIDAL VOLUME OF 1980MLS. THIS INFO GIVES A TOTAL DRAIN VOLUME OF 3226MLS (1246MLS + 1980MLS). NO PT INJURY OR MEDICAL INTERVENTION WAS REPORTED. DESPITE BAXTER'S ATTEMPTS, NO ADDITIONAL INFO COULD BE OBTAINED REGARDING THIS EVENT.

    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 63 YR