BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OUTLOOK 200

    MDR report key: 1033144 · Received April 22, 2008

    Report

    Report Number
    1641965-2008-00025
    Event Type
    Malfunction
    Date Received
    April 22, 2008
    Report Date
    February 26, 2008
    Manufacturer
    B. BRAUN MEDICAL, INC.
    Product Code
    FRN
    PMA / PMN Number
    K011975
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL RESULTS WILL BE SUBMITTED WHEN EVAL IS COMPLETE.

    Description of Event or Problem · 1

    DEVICE WAS RETURNED DUE TO REPORTED BLOOD BACKFLOW IN TUBING. PUMP WAS BEING USED ON A PT. THERE WAS NO INJURY. THE PUMP RAN AT A LOW RATE, 5ML/HR DEXTROSE 5%. USED 375196 ULTRASITE US3140 LOT NUMBER, 24 GA NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OUTLOOK 200 INFUSION PUMP FRN B. BRAUN MEDICAL, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 6 MO