BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OUTLOOK 200 SAFETY INFUSION PUMP

    MDR report key: 3364195 · Received August 8, 2013

    Report

    Report Number
    3364195
    Event Type
    Malfunction
    Date Received
    August 8, 2013
    Date of Event
    July 31, 2013
    Report Date
    August 8, 2013
    Manufacturer
    B. BRAUN MEDICAL, INC.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    AT 2030 THE IV PUMP RUNNING HYPERALIMENTATION MIX (SBT) AT 4ML/HR ALARMED WITH THE MESSAGE "BAG EMPTY."INFUSION "HELD" AND PICC LINE CLAMPED. CASSETTE REMOVED AND AIR/BUBBLES WERE FOUND IN THE TUBING. SBT RUNS FOR 24 HOURS FROM 2300 ONE DAY TO 2300 THE NEXT AND PHARMACY FILLS THE MEDICATION. THE SBT BAG SAID IT HAD 100ML OVERFILL." MD NOTIFIED AND CONCERNED THAT INFANT POSSIBLY RECEIVED AN EXTRA 100ML OF SBT & COULD BE IN FLUID OVERLOAD & ELECTROLYTES COULD BE ABNORMAL. LABS DRAWN. PATENT DID NOT REQUIRE INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    375884 OUTLOOK 200 SAFETY INFUSION PUMP PUMP, INFUSION FRN B. BRAUN MEDICAL, INC. OUTLOOK SAFETY INFUSION SYSTEM A1930

    Patients

    Seq Age Sex Outcome Treatment
    1 4 DA