BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PD CYCLER 110 VOLT HOME CHOICE PRO AUTOMATED

    MDR report key: 1030331 · Received April 16, 2008

    Report

    Report Number
    1423500-2008-00253
    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. 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 2. THE PT'S ULTRAFILTRATION READING WAS 786ML INDICATING THE HOME PT (HP) DRAINED 786ML MORE THAN THEIR PROGRAMMED FILL VOLUME OF 2000ML. THIS INFO GIVES A TOTAL DRAIN VOLUME OF 2786ML (2000ML + 786ML). NO PT INJURY OR MEDICAL INTERVENTION WAS REPORTED. DESPITE REPEATED ATTEMPTS BY BAXTER, 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 CHOICE PRO AUTOMATED 78FKX FKX BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1