BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CVVHD

    MDR report key: 1010509 · Received February 12, 2008

    Report

    Report Number
    1010509
    Event Type
    Malfunction
    Date Received
    February 12, 2008
    Date of Event
    February 11, 2008
    Report Date
    February 12, 2008
    Manufacturer
    NXSTAGE MEDICAL, INC.
    Product Code
    KDI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    THE CVVHD (CONTINUOUS VENOVENOUS HEMODIALYSIS) MACHINE TURNED OFF. STAFF WAS UNABLE TO TURN THE MACHINE BACK ON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CVVHD DIALYSIS MACHINE KDI NXSTAGE MEDICAL, INC. * L 0 7 2 2 5 0

    Patients

    Seq Age Sex Outcome Treatment
    1 *