BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OUTLOOK ES

    MDR report key: 3142942 · Received May 30, 2013

    Report

    Report Number
    1641965-2013-00027
    Event Type
    Malfunction
    Date Received
    May 30, 2013
    Report Date
    May 3, 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
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED COMPLAINT WAS NOT CONFIRMED, NOR WAS IT DUPLICATED. THE OPERATION LOG GIVES NO INDICATION OF THE REPORTED PROBLEM BUT DOES SHOW SYSTEM ERRORS 75 AND 123, WHICH INDICATES THE PUMP DID HAVE A MALFUNCTION THAT WOULD INTERRUPT OR STOP ANY ONGOING DELIVERY OR OTHER OPERATING MODE. THEREFORE, THE PUMP WAS TESTED (RUN) FOR 96 HOURS AS PART OF THIS INVESTIGATION. THERE WERE NO FAILURES DURING THAT PERIOD. ADDITIONALLY, DURING THIS INVESTIGATION, THE BACKUP ALARM WAS TESTED AND FOUND TO BE FUNCTIONAL.

    Description of Event or Problem · 1

    WHILE IN USE ON PATIENT, INFUSION STOPPED WITHOUT NOTIFICATION ALARM, NURSES STATE SCREEN FLASHING AN UNABLE TO ENTER ANYTHING ONTO KEYPAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237884 OUTLOOK ES INFUSION PUMP FRN B. BRAUN MEDICAL, INC. OUTLOOK 400 ES

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention