BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT SPACE

    MDR report key: 2172014 · Received July 12, 2011

    Report

    Report Number
    2172014
    Event Type
    Malfunction
    Date Received
    July 12, 2011
    Date of Event
    June 22, 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

    A 100 ML BAG MORPHINE BAG WAS HUNG AT 1410. THE CLINICAL COORDINATOR FROM THE AM SHIFT AND THE ONCOMING CHARGE RN COMPLETED ROUNDING OF ALL PATIENTS AT THE END OF THE SHIFT. THEY CONFIRMED THE AMOUNT IN THE BAG AND PUMP SETTINGS AT 1 MG/HR. AT 2240, THE ENTIRE BAG HAD BEEN INFUSED (8 HOURS INSTEAD OF 24 HOURS). THE PUMP WAS REMOVED FROM THE BEDSIDE AND NEW MORPHINE DRIP TUBING AND PUMP WAS STARTED. THE PUMP HISTORY INDICATED THE PUMP WAS SET AT THE CORRECT RATE. INSPECTION OF THE BAG AND TUBING DID NOT REVEAL ANY LEAKS OR HOLES. THERE WAS NO CHANGE IN THE PATIENT ASSESSMENT OR CONDITION. NO HARM TO THE PATIENT. 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 RECEIVED AS YET.======================MANUFACTURER RESPONSE FOR INFUSION PUMP, INFUSOMAT SPACE (PER SITE REPORTER)======================THE CNO OF THE HOSPITAL CALLED 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 REPORTED TO MEDSUN. HE STATED HE WAS NOT AWARE OF ANY OTHER REPORTS LIKE THIS ONE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR NO OTHER THERAPIES