BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OUTLOOK ES

    MDR report key: 1844748 · Received September 23, 2010

    Report

    Report Number
    1641965-2010-00075
    Event Type
    Malfunction
    Date Received
    September 23, 2010
    Date of Event
    August 26, 2010
    Report Date
    August 27, 2010
    Manufacturer
    B. BRAUN MEDICAL, INC.
    Product Code
    FRN
    PMA / PMN Number
    K011975
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED DEVICE WAS RECEIVED ON (B)(4) 2010. THE EVAL IS CURRENTLY UNDERWAY. A F/U REPORT WILL BE INITIATED AFTER THE EVAL IS COMPLETE.

    Description of Event or Problem · 1

    PUMP DIDN'T GO ON-HOLD DURING INFUSION. PUMP WAS INFUSING NEOSYNEPHRINE (RATE/VOLUME CURRENTLY UNAVAILABLE). NURSES PRESSED HOLD BUTTON UP TO TEN TIMES, BUT THE HOLD BUTTON DID NOT WORK. TO STOP THE INFUSION, FACILITY HAD TO TURN THE PUMP OFF. THE DEVICE WAS IN USE ON A PT. PT STATUS CURRENTLY UNAVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1