BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRISMA

    MDR report key: 650501 · Received December 5, 2005

    Report

    Report Number
    MW1037361
    Event Type
    Malfunction
    Date Received
    December 5, 2005
    Date of Event
    November 23, 2005
    Report Date
    November 28, 2005
    Manufacturer
    GAMBRO, INC.
    Product Code
    KDI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    PRISMA MACHINE ALARMED (MICRO AIR). RN WENT IN AND FOUND BLOOD ON FACEPLATE OF MACHINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRISMA HEMODIALYSIS UNIT KDI GAMBRO, INC. 018080001D *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other