BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OUTLOOK

    MDR report key: 2160326 · Received May 16, 2011

    Report

    Report Number
    1641965-2011-00034
    Event Type
    Malfunction
    Date Received
    May 16, 2011
    Report Date
    April 18, 2011
    Manufacturer
    B. BRAUN MEDICAL, INC.
    Product Code
    FRN
    PMA / PMN Number
    K011975
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE EVALUATION IS UNDERWAY. A F/U REPORT WILL BE SUBMITTED AFTER THE EVAL IS COMPLETE.

    Description of Event or Problem · 1

    PUMP OVERINFUSION - SET TO RUN FOR 3 HOURS AND INFUSED WITHIN 1 HOUR. NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OUTLOOK INFUSION PUMP FRN B. BRAUN MEDICAL, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK