BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDSYSTEM III INFUSION PUMP

    MDR report key: 2901310 · Received December 20, 2012

    Report

    Report Number
    2016493-2012-00529
    Event Type
    Injury
    Date Received
    December 20, 2012
    Date of Event
    August 28, 2012
    Report Date
    November 30, 2012
    Manufacturer
    CAREFUSION CORP.
    Product Code
    FRN
    PMA / PMN Number
    K933545
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ALTHOUGH THE DEVICE WAS REQUESTED, THE CUSTOMER REPORTED THAT THEY WILL NOT BE SENDING THE DEVICE IN FOR EVALUATION. THEY HAVE DETERMINED THE PROBLEM TO BE A USER ISSUE.

    Description of Event or Problem · 1

    A CUSTOMER MEDWATCH WAS RECEIVED. THE EVENT DESCRIPTION STATES: PATIENT RECEIVED FROM E.R. AT 2010. WAS STARTED ON DOPAMINE DRIP IN E.R. AT 1930. PATIENT PUT INTO BED AND ON INITIAL ASSESSMENT HEART RATE WAS 140-160/MIN. DOPAMINE DRIP WAS NOTED TO BE INFUSED ALREADY, 250CC'S. MINIMED CASSETTE ON PUMP, ONLY HALF WAY IN, SO IV IN FREE FLOWING POSITION. PATIENT STATED DOWNSTAIRS (IN ED) HE FELT LIKE HIS 'HEART WAS THUMPING LIKE A JACK HAMMER'. WHEN HIS BROTHER CAME INTO ROOM HE ALSO STATED PATIENT'S 'HEART RATE DOWNSTAIRS WAS REALLY HIGH' AND PATIENT WAS 'BEET RED LIKE A LOBSTER ALL OVER' WHEN IN E.R. 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." THE CUSTOMER CONTACT STATED THAT THE PATIENT WAS DISCHARGED HOME WITH NO LONG TERM AFFECTS FROM THE EVENT. THEY ALSO STATED THAT THEY BELIEVE THE PROBLEM WAS A USER ISSUE SINCE THE CASSETTE WAS NOT PROPERLY LOADED INTO THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDSYSTEM III INFUSION PUMP FRN CAREFUSION CORP. 2865 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Other THERAPY DATE:| MODEL/LOT # UNK| MSIII IV PUMP INFUSION MODULE ADMINISTRATION SET,