BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OUTLOOK ES

    MDR report key: 2160325 · Received May 16, 2011

    Report

    Report Number
    1641965-2011-00035
    Event Type
    Malfunction
    Date Received
    May 16, 2011
    Date of Event
    April 18, 2011
    Report Date
    April 19, 2011
    Manufacturer
    B. BRAUN MEDICAL, INC.
    Product Code
    FRN
    PMA / PMN Number
    K011975
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVAL IS CURRENTLY UNDERWAY. A F/U REPORT WILL BE INITIATED WHEN THE EVAL IS COMPLETE.

    Description of Event or Problem · 1

    UNDER-INFUSION. NO PT INJURY REPORTED. DRUG BEING ADMINISTERED WAS PITOCIN IN THE LABOR AND DELIVERY DEPT. THE THERAPY WAS CONTINUOUS. THE DEVICE RAN FOR 3 HOURS BEFORE THE OCCURRENCE. THE RATE WAS SET FOR 30ML/HR; HOWEVER, IT WAS CHANGED A FEW TIMES BY THE USER. APPROX 270ML REMAINED IN THE IV CONTAINER. THE DEVICE WAS SWAPPED OUT WITH A DIFFERENT DEVICE, WHICH RAN WITHOUT ISSUES AT THE SAME SETTINGS WITH THE SAME CASSETTE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK