BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRISMA

    MDR report key: 653229 · Received December 13, 2005

    Report

    Report Number
    MW1037220
    Event Type
    Malfunction
    Date Received
    December 13, 2005
    Date of Event
    November 26, 2005
    Report Date
    December 13, 2005
    Manufacturer
    GAMBRO - DASCO SPA
    Product Code
    FII
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT WAS TO BE STARTED ON CRRT, RN ATTEMPTED TO PRIME CRRT MACHINE "PEE WEE" THREE TIMES AND MOST MALFUNCTION CODES (0040, 0060, 0050) RESPECTIVELY. SPOKE WITH GAMBRO REP TWICE REGARDING THIS MATTER, WHO DETERMINED THE MACHINE WAS DEFECTIVE AND IN NEED OF REPAIR. DELAY IN STARTING CRRT IN PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRISMA PRISMA CRRT MACHINE "PEE WEE" FII GAMBRO - DASCO SPA * *

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other