BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE CYCLER-REFURBISHED

    MDR report key: 1030822 · Received April 17, 2008

    Report

    Report Number
    1423500-2008-00263
    Event Type
    Malfunction
    Date Received
    April 17, 2008
    Date of Event
    February 11, 2008
    Report Date
    April 10, 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

    ADD'L PMA 510(K): K923065. 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 LOG DATA, THE EVAL HAS DETERMINED THE MOST PROBABLE CAUSE OF THE OVERFILL TO BE A CATHETER ISSUE, INSUFFICIENT DRAIN, USER ERROR BECAUSE DRAIN AND A NEGATIVE ULTRAFILTRATION ALARM WAS BYPASSED, AND A FALSE EMPTY DETECT. THE DEVICE WILL BE ROUTED TO THE SVC AREA.

    Description of Event or Problem · 1

    DURING EVAL OF A RETURNED HOMECHOICE MACHINE, A POSSIBLE OVERFILL SITUATION WAS IDENTIFIED WHICH OCCURRED IN 2008, DURING DRAIN CYCLE 6. THE PT'S ULTRAFILTRATION READING WAS 2108ML INDICATING THE HOME PT (HP) DRAINED 2108ML MORE THAN THEIR PROGRAMMED FILL VOLUME OF 2500ML. THIS INFO GIVES A TOTAL DRAIN VOLUME OF 4608ML (2500ML + 2108ML). THE HP IS DOING FINE AND HAS BEEN ABLE TO CONTINUE PERITONEAL DIALYSIS THERAPY WITHOUT ANY FURTHER PROBLEMS. NO SERIOUS PT INJURY OR MEDICAL INTERVENTION WAS REPORTED. DESPITE BAXTER'S ATTEMPTS, NO ADD'L 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