BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE CYCLER-REFURBISHED

    MDR report key: 1073924 · Received July 9, 2008

    Report

    Report Number
    1423500-2008-00621
    Event Type
    Malfunction
    Date Received
    July 9, 2008
    Date of Event
    June 21, 2008
    Report Date
    June 21, 2008
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FKX
    PMA / PMN Number
    K012988
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4).

    Description of Event or Problem · 1

    A HOME PATIENT (HP) CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING THE HOMECHOICE (HP) THERAPY AND REPORTED FEELING OVERFILLED IN FILL 1 OF 5 CYCLE. THE PT HAD ABDOMINAL DISTENSION AND BLOATING. BAXTER'S TECHNICAL SVC REP (TSR) ASSISTED HP WITH MANUAL DRAIN AND MANUALLY DRAINED OFF 5193ML. THE LAST VOLUME INFUSED WAS 2982ML. THE INITIAL DRAIN ALARM SETTING (IDA) WAS 0ML. THE HP WANTED TO RESUME THERAPY AND WAS ROUTED BACK TO FILL 1 CYCLE. THE HP WILL SPEAK TO THE NURSE ABOUT PUTTING A VALUE IN THE IDA SETTING. THE HP JUST RECENTLY STARTED DOING MANUAL EXCHANGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE CYCLER-REFURBISHED 78FKX FKX BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR