BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OUTLOOK

    MDR report key: 3167714 · Received June 11, 2013

    Report

    Report Number
    1641965-2013-00032
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Date of Event
    March 19, 2013
    Report Date
    May 14, 2013
    Manufacturer
    B. BRAUN MEDICAL, INC.
    Product Code
    FRN
    PMA / PMN Number
    K011975
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED COMPLAINT WAS CONFIRMED. SOLENOID HAD OVERHEATED. REPLACED SOLENOID #113007, LEFT STANDOFF #401542, RIGHT STANDOFF #401543. PERFORMED PREVENTATIVE MAINTENANCE SERVICE.

    Description of Event or Problem · 1

    PAIN MEDICATION NEEDED POST SURGERY WAS NOT BEING DELIVERED TO A PT DUE TO THE OUTLOOK 100 PUMP FREQUENTLY DISPLAYING AN EMPTY BAG ALARM. THE PT WAS IN PAIN DUE TO THE TREATMENT BEING DELAYED. THE NURSE HAD TO FREQUENTLY RESTART THE PUMP

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263901 OUTLOOK INFUSION PUMP FRN B. BRAUN MEDICAL, INC. OUTLOOK 100

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention