BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE CYCLER-REFURBISHED

    MDR report key: 1003211 · Received February 25, 2008

    Report

    Report Number
    1423500-2008-00102
    Event Type
    Malfunction
    Date Received
    February 25, 2008
    Date of Event
    February 1, 2008
    Report Date
    February 1, 2008
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FKX
    PMA / PMN Number
    K012988
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING NEGATIVE ULTRAFILTRATION ALARM DURING DRAIN 3 OF 5. DRAIN VOLUME IS 2151ML. FILL VOLUME IS 1500ML. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE NURSE TO CLOSE AND OPEN THE TRANSFER SET AND HAVE THE HOME PATIENT (HP) MOVE OVER. THERE IS NO FIBRIN. THE HP SAYS HE IS EMPTY. BYPASS TO FILL COMPLETED. FOLLOW-UP WITH NURSE WAS ATTEMPTED.

    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