BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRISMA

    MDR report key: 1172464 · Received September 16, 2008

    Report

    Report Number
    1172464
    Event Type
    Malfunction
    Date Received
    September 16, 2008
    Date of Event
    August 12, 2008
    Report Date
    September 16, 2008
    Manufacturer
    GAMBRO RENAL PRODUCTS, INC.
    Product Code
    KDI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    CRRT MACHINE STOPPED IN MIDDLE OF EXCHANGE AND READ,"CALIBRATION/SERVICE NEEDED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRISMA DIALYSIS MACHINE, CRRT KDI GAMBRO RENAL PRODUCTS, INC. ID 4335-2 *

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR