BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PD CYCLER 110 VOLT HOME CHOICEPRO AUTOMATED

    MDR report key: 1064168 · Received June 18, 2008

    Report

    Report Number
    1423500-2008-00509
    Event Type
    Malfunction
    Date Received
    June 18, 2008
    Date of Event
    January 2, 2008
    Report Date
    June 6, 2008
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FKX
    PMA / PMN Number
    K012988
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL 510(K) NUMBER: K923065. EVAL SUMMARY: THE EVAL DID NOT CONFIRM ANY FAILURE OR MALFUNCTION OF THE DEVICE THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE OVERFILL IDENTIFIED DURING EVAL. BASED ON A REVIEW OF ALL THE DEVICE LOG DATA, IT WAS DETERMINED THAT THE PROBABLE CAUSE OF THE OVERFILL WAS FALSE EMPTY DETECT AT INITIAL DRAIN AND AT PREVIOUS THERAPY LAST DRAIN.

    Description of Event or Problem · 1

    DURING EVAL OF A RETURNED HOMECHOICE DEVICE, A BAXTER TECH IDENTIFIED A POTENTIAL OVERFILL SITUATION. DURING THERAPY IN 2008, A HOME PT HAD AN ULTRAFILTRATION OF 780ML IN DRAIN 1 FOLLOWING A FILL VOLUME OF 2200ML. THE HOME PT'S NURSE DECLINED TO PROVIDE FURTHER INFO 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