BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PD CYCLER 110 VOLT HOME CHOICEPRO AUTOMATED

    MDR report key: 1030301 · Received April 15, 2008

    Report

    Report Number
    1423500-2008-00240
    Event Type
    Malfunction
    Date Received
    April 15, 2008
    Date of Event
    February 18, 2008
    Report Date
    April 8, 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 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 THERAPY LOG DATA, THE EVAL HAS DETERMINED THE MOST PROBABLE CAUSE IS: INSUFFICIENT DRAIN, FALSE EMPTY DETECT, AND USE ERROR DUE TO INAPPROPRIATELY SETTING THE TOTAL ULTRAFILTRATION TOO LOW.

    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 1288ML INDICATING THE HOME PATIENT (HP) DRAINED 1288ML MORE THAN THEIR PROGRAMMED FILL VOLUME OF 2000ML. THIS INFO GIVES A TOTAL DRAIN VOLUME OF 3288ML (2000ML + 1288ML). THE HP IS DOING WELL AND HAS BEEN ABLE TO CONTINUE PERITONEAL DIALYSIS THERAPY WITHOUT ANY FURTHER PROBLEMS. NO 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 PD CYCLER 110 VOLT HOME CHOICEPRO AUTOMATED 78FKX FKX BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1