BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PD CYCLER 110 VOLT HOME CHOICE PRO AUTOMATED

    MDR report key: 1030330 · Received April 16, 2008

    Report

    Report Number
    1423500-2008-00252
    Event Type
    Malfunction
    Date Received
    April 16, 2008
    Date of Event
    December 3, 2007
    Report Date
    March 19, 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 510K#: 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, ALARM AND EVENT LOG DATA, THE EVAL HAS DETERMINED THAT THE MOST PROBABLE CAUSE FOR THESE OVERFILLS WAS INSUFFICIENT DRAIN/FALSE EMPTY DETECT/MULTIPLE CYCLES ADVANCE TO FILL WHEN SLOW / NO FLOW OCCURRED ABOVE THE MIN DRAIN VOLUME THRESHOLD AND USER ERROR. THE INITIAL DRAIN ALARM SETTING WAS INAPPROPRIATELY PROGRAMMED TOO LOW (LAST FILL- 1500ML, INITIAL DRAIN ALARM= 50 ML). THE DEVICE WILL BE ROUTED TO THE SERVICE AREA.

    Description of Event or Problem · 1

    DURING EVAL OF A RETURNED HOMECHOICE MACHINE, A POSSIBLE OVERFILL SITUATION WAS IDENTIFIED WHICH OCCURRED IN 2007, DURING DRAIN CYCLE 1 . THE PT'S ULTRAFILTRATION READING WAS 675ML, INDICATING THE HOME PT (HP) DRAINED 675ML MORE THAN THEIR PROGRAMMED FILL VOLUME OF 2000ML. THIS INFO GIVES A TOTAL DRAIN VOLUME OF 2675ML (2000ML + 675ML). NO PT INJURY OR MEDICAL INTERVENTION WAS REPORTED. DESPITE REPEATED ATTEMPTS BY BAXTER, NO ADD'L INFORMATION COULD BE OBTAINED REGARDING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PD CYCLER 110 VOLT HOME CHOICE PRO AUTOMATED 78FKX FKX BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1