BEUDAMED
    FDA Adverse Event Summary report: N

    MEDSYSTEM III

    MDR report key: 2843701 · Received October 29, 2012

    Report

    Report Number
    2843701
    Date Received
    October 29, 2012
    Date of Event
    August 28, 2012
    Report Date
    October 29, 2012
    Manufacturer
    CAREFUSION
    Product Code
    FRN
    Report Source
    User Facility report
    Reporter Location
    OR, US

    Narratives

    Description of Event or Problem · 1

    TAKEN FROM INTERNAL REPORTING SYSTEM: "PATIENT RECEIVED FROM ER AT 2010. WAS STARTED ON DOPAMINE DRIP IN ER AT 1930. PATIENT PUT INTO BED AND ON INITIAL ASSESSMENT HEART RATE WAS 140-160/MIN. DOPAMINE DRIP WAS NOTED TO BE INFUSED ALREADY, 250 CC'S. MINIMED CASSETTE ON PUMP, ONLY HALF WAY IN, SO IV IN FREE FLOWING POSITION. PT STATED DOWNSTAIRS IN ED HE FELT LIKE HIS" HEART WAS THUMPING LIKE A JACK HAMMER". WHEN HIS BROTHER CAME INTO ROOM HE ALSO STATED PATIENTS "HEART RATE DOWNSTAIRS WAS REALLY HIGH" AND PATIENT WAS "BEET RED LIKE A LOBSTER ALL OVER" WHEN IN ER. SO IT APPEARS THE DOPAMINE INFUSION ALL WENT INTO THE PATIENT IN ABOUT 45 MINUTES WITH ADVERSE HEMODYNAMIC RESPONSES."IT WAS FELT TO BE STRICTLY A USER ISSUE, IN OTHER WORDS, AN ERGONOMIC OR DESIGN ISSUE RATHER THAN A PUMP FAILURE. BIOMED COULD NOT FIND ANY DEFECT WITH THE MACHINE, AND AFTER BEING CHECKED OUT IT WAS RETURNED TO SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDSYSTEM III PUMP, INFUSION FRN CAREFUSION 2860D *

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR CARDIAC DRUGS