BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 3904400 · Received June 13, 2014

    Report

    Report Number
    3904400
    Event Type
    Malfunction
    Date Received
    June 13, 2014
    Date of Event
    October 7, 2013
    Report Date
    June 13, 2014
    Manufacturer
    CAREFUSION
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WITH NO CHANGE IN IV PUMP OR SETTING, CHANNEL SHUT DOWN AND SAID CHANNEL ERROR. WOULD NOT RESTART. PUMP CHANNEL WAS RUNNING LEVOPHED 4% STRENGTH ON LEVOPHED DEPENDENT PATIENT. RN OUTSIDE ROOM WITNESSED EVENT AND INTERVENED PRIOR TO PATIENT HARM. PUMP REMOVED FROM SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351452 * PUMP, INFUSION FRN CAREFUSION 8100 *

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR