BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OUTLOOK

    MDR report key: 2151612 · Received June 24, 2011

    Report

    Report Number
    1641965-2011-00039
    Event Type
    Malfunction
    Date Received
    June 24, 2011
    Date of Event
    May 25, 2011
    Report Date
    May 26, 2011
    Manufacturer
    B. BRAUN MEDICAL, INC.
    Product Code
    FRN
    PMA / PMN Number
    K011975
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE EVAL IS UNDERWAY. A FOLLOW-UP REPORT WILL BE SUBMITTED AFTER THE EVAL IS COMPLETE.

    Description of Event or Problem · 1

    PUMP OVERINFUSION. PT WAS AN INFANT RECEIVING LIPIDS. WHILE ON HOLD, THE PUMP JUMPED FROM 1.4 TO 11.4. THE PUMP WAS REMOVED AND TAKEN TO THE BIOMED. THE PT WAS FINE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK