BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT SPACE

    MDR report key: 1915421 · Received November 5, 2010

    Report

    Report Number
    1641965-2010-00103
    Event Type
    Malfunction
    Date Received
    November 5, 2010
    Date of Event
    September 28, 2010
    Report Date
    October 7, 2010
    Manufacturer
    B. BRAUN MEDICAL, INC.
    Product Code
    FRN
    PMA / PMN Number
    K062700
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVALUATION IS ON-GOING. A FOLLOW-UP REPORT WILL BE INITIATED AFTER THE COMPLETION OF THE EVALUATION.

    Description of Event or Problem · 1

    REPORTED OVER-INFUSION. THE DEVICE WAS BEING USED IN THE CSU DEPARTMENT. IT WAS SET TO RUN CONTINUOUSLY (DRUG UNK) AT A RATE OF 12.8 CC/HR. FIVE TO SIX HOURS LATER THE PUMP HAD AN AIR-IN-LINE ALARM AND BAG EMPTY ALARM. NOTHING WAS REMAINING IN THE IV BAG. NO FURTHER INFO IS AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1