BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT SPACE S

    MDR report key: 2171935 · Received July 12, 2011

    Report

    Report Number
    2171935
    Event Type
    Malfunction
    Date Received
    July 12, 2011
    Date of Event
    June 27, 2011
    Report Date
    July 12, 2011
    Manufacturer
    B. BRAUN
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    RN BEGAN BUMETANIDE DRIP PER MD ORDER. PRIMED IV LINE AND PLACED IN INFUSION PUMP. SET THE INFUSION PUMP TO RUN AT 1 ML/HR WITH VOLUME TO BE INFUSED AT 15 MLS (DOSAGE WAS 0.25 MG/ML WITH THE IV BAG CONTAINING 20 MLS) AT 1226. AT APPROXIMATELY 1400, CHECKED THE BUMEX WHEN HANDING PATIENT OFF TO ANOTHER RN. THE ENTIRE BAG HAD INFUSED. CHECKED THE PUMP SETTINGS WHICH SHOWED 1 ML/HR WITH MORE THAN 13 MLS LEFT TO INFUSE. CHECKED THE FLOOR AND PATIENT BED FOR ANY EXTRA FLUID. IV BAG CHECKED AND NO HOLES IDENTIFIED. CONTACTED THE MD WHO WAS OK WITH THE 5 MG DOSE. ORDERS TO STOP BUMEX DRIP FOR NOW WITH THE POSSIBILITY OF RESTARTING THE DRIP ON NIGHT SHIFT. NO HARM TO THE PATIENT. REVIEW OF THE PUMP HISTORY INDICATED THAT THE PUMP WAS SET AT THE CORRECT RATE. THE PUMP WAS SENT FOR EVALUATION TO A THIRD PARTY CONSULTANT. TESTING OF THE PUMP DID NOT REVEAL ANY FAILURE THAT WOULD CONTRIBUTE TO A GROSS INFUSION DELIVERY ERROR. THE PUMP HAS BEEN RETURNED TO B.BRAUN FOR THEIR EVALUATION OF THE PUMP. NO REPORT RECIEVED AS YET.======================MANUFACTURER RESPONSE FOR INFUSION PUMP, INFUSOMAT SPACE S (PER SITE REPORTER)======================THE CNO OF THE HOSPTIAL CALLED (B)(4), SENIOR INFUSION SYSTEMS SPECIALIST TO DISCUSS OUR CONCERNS ABOUT THIS EVENT AND TWO OTHERS THAT HAPPENED IN A SHORT PERIOD OF TIME THAT ARE ALSO BEING ENTERED INTO MEDSUN. HE STATED HE WAS NOT AWARE OF ANY OTHER REPORTS LIKE THESE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFUSOMAT SPACE S INFUSION PUMP FRN B. BRAUN 8713050U *

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR