BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CYCLER 220 VOLT HOMECHOICE PROAUTOMATED PD

    MDR report key: 1012747 · Received March 12, 2008

    Report

    Report Number
    1423500-2008-00150
    Event Type
    Malfunction
    Date Received
    March 12, 2008
    Date of Event
    March 11, 2008
    Report Date
    March 11, 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

    THE DEVICE HAS BEEN REQUESTED FOR EVAL, BUT HAS NOT BEEN REC'D. A F/U WILL BE SUBMITTED WHEN EVAL RESULTS ARE AVAILABLE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SVC CTR REGARDING ABNORMAL DISTENSION DURING THERAPY ON A HOMECHOICE DEVICE. THE HOME PT HAD PERFORMED A MANUAL EXCHANGE IN 2008 AND FILLED WITH 1700 ML OF A PRESCRIBED 2000 ML. THE HOME PT THEN STARTED THERAPY ON THE HOMECHOICE DEVICE LATER THAT DAY. THE INITIAL DRAIN VOLUME WAS 864 ML AND THE HOMECHOICE MOVED TO FILL 1 OF 5. THE INITIAL DRAIN ALARM WAS SET TO 800 ML. THE HOME PT STOPPED THE FILL AT A VOLUME OF 1823 ML. THE TECHNICAL SVC REP (TSR) HAD THE HOME PT GO TO MANUAL DRAIN AND DRAINED 2950 ML. THE HOME PT WANTED TO END THERAPY AT THAT POINT. TSR HAD HOME PT CYCLE THE POWER AND END THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYCLER 220 VOLT HOMECHOICE PROAUTOMATED PD 78FKX FKX BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1