BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMPOWER CT INJECTOR WITH EDA

    MDR report key: 385299 · Received March 25, 2002

    Report

    Report Number
    2432460-2002-00007
    Event Type
    Malfunction
    Date Received
    March 25, 2002
    Date of Event
    February 21, 2002
    Report Date
    February 21, 2002
    Manufacturer
    E-Z-EM, INC.
    Product Code
    JAK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INJECTOR SYSTEM'S FLOW RATE WAS SET FOR 1.6CC/SEC, WITH A TOTAL INJECTION VOLUME OF 100 ML NON-IONIC CONTRAST. DURING A DEMONSTRATION OF THE UNIT AN EXTRAVASATION OCCURRED IN THE LEFT ANTECUBITAL AREA THAT THE EDA SYSTEM FAILED TO PAUSE AND DETECT. THE PATIENT WAS TREATED WITH WARM COMPRESSES AND THE FACILITY PROVIDED AN INSTRUCTION SHEET ON SITE AND THE PATIENT'S ARM WAS SLIGHTLY FLABBY. THE TECHNICIAN DID NOT NOTICE THAT AN EXTRAVASATION HAD OCCURRED UNTIL APPROXIMATELY 40CC'S OF CONTRAST WAS INFILTRATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EMPOWER CT INJECTOR WITH EDA CT INJECTOR W/EXTRAVASATION ACCESSORY JAK E-Z-EM, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other ULTRAVIST 300 NON-IONIC CONTRAST.