BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OUTLOOK 100

    MDR report key: 1191089 · Received September 26, 2008

    Report

    Report Number
    1641965-2008-00073
    Event Type
    Malfunction
    Date Received
    September 26, 2008
    Report Date
    September 3, 2008
    Manufacturer
    B. BRAUN MEDICAL, INC.
    Product Code
    FRN
    PMA / PMN Number
    K011975
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION RESULTS WILL BE SUBMITTED WHEN EVALUATION IS COMPLETED.

    Description of Event or Problem · 1

    REPORTEDLY, THE RATE CHANGED DURING INFUSION, LEADING TO AN OVERINFUSION. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OUTLOOK 100 INFUSION PUMP FRN B. BRAUN MEDICAL, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1