BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OUTLOOK

    MDR report key: 3610391 · Received November 5, 2013

    Report

    Report Number
    1641965-2013-00071
    Event Type
    Malfunction
    Date Received
    November 5, 2013
    Date of Event
    July 31, 2013
    Report Date
    October 2, 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
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULTS: AFTER REVIEWING THE OPERATIONAL LOG THE COMPLAINT FOR THE PUMP OVER INFUSING WAS NOT CONFIRMED. ON (B)(6) 2013 AT 12:01AM AN INFUSION WAS STARTED TO INFUSE 50ML AT A RATE OF 3.8 ML/HR. AT 11:01AM THE INFUSION WAS MANUALLY STOPPED. THE PUMP INFUSED 41.7 ML AND THE VOLUME INFUSED RELATIVE TO THE INFUSION TIME WAS 100% ACCURATE. AT 12:59PM THE INFUSION WAS STARTED AGAIN WITH A VOLUME TO INFUSE OF 50.3ML AT A RATE OF 4 ML/HR. AT 11:34PM THE INFUSION WAS MANUALLY STOPPED. THE PUMP INFUSED 42.2 ML AND THE VOLUME INFUSED RELATIVE TO THE INFUSION TIME WAS 100% ACCURATE. ON (B)(6) 2013 AT 12:04AM AN INFUSION WAS STARTED TO INFUSE 48 ML AT A RATE OF 4 ML/HR. AT 12:00PM THE INFUSION WAS MANUALLY STOPPED. THE PUMP INFUSED 47.7 ML AND THE VOLUME INFUSED RELATIVE TO THE INFUSION TIME WAS 100% ACCURATE. AT 12:00PM THE INFUSION WAS STARTED AGAIN WITH A VOLUME TO INFUSE OF 48 ML AT A RATE OF 4 ML/HR. AT 8:25PM THE PUMP ALARMED AN EMPTY CONTAINER AND THE INFUSION AUTOMATICALLY STOPPED. A 33.6 ML HAD BEEN INFUSED DURING THIS TIME FRAME WHERE THE VOLUME INFUSED RELATIVE TO THE INFUSION TIME WAS 100% ACCURATE.

    Description of Event or Problem · 1

    AT 2030 THE IV PUMP RUNNING HYPERALIMENTATION MIX (SBT) AT 4 ML/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 100 ML OVERFILL. MD NOTIFIED AND CONCERNED THAT INFANT POSSIBLY RECEIVED AN EXTRA 100 ML OF SBT AND COULD BE IN FLUID OVERLOAD ELECTROLYTES COULD BE ABNORMAL. LABS DRAWN. PATIENT DID NOT REQUIRE INTERVENTION. WHAT WAS THE ORIGINAL INTENDED PROCEDURE: INFUSE IV FLUIDS AT A RATE PER MD ORDER. DEVICE USAGE PROBLEM: DEVICE MALFUNCTION - THAT IS, THE DEVICE DID NOT DO WHAT IT WAS SUPPOSED TO DO. DEVICE IS AVAILABLE FOR EVALUATION. AFTER FURTHER FOLLOW-UP WITH THE REPORTER THERE WERE NO PATIENT INJURIES WITH THE EVENT. THE BIOMED WAS UNABLE TO LOCATE THE PUMP IN THE FACILITY TO SEND BACK FOR RETURN BUT DID PROVIDE THE OPERATIONAL LOG OF THE PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    569808 OUTLOOK INFUSION PUMP FRN B. BRAUN MEDICAL, INC. 620-200

    Patients

    Seq Age Sex Outcome Treatment
    1 Other