BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERCUPUMP CT INJECTOR WITH EDA

    MDR report key: 279954 · Received May 25, 2000

    Report

    Report Number
    2432460-2000-00018
    Event Type
    Malfunction
    Date Received
    May 25, 2000
    Date of Event
    April 20, 2000
    Report Date
    April 24, 2000
    Manufacturer
    E-Z-EM, INC.
    Product Code
    FIH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INJECTOR FLOW RATE WAS SET FOR 2.5CC/SEC. AND THE INJECTION SITE WAS THE RIGHT ANTECUBITAL FOSSA. AFTER COMPLETION OF THE PROCEDURE (TOTAL OF 150ML INJECTED), THE TECHNICIAN NOTICED A LARGE EXTRAVASATION ON THE ARM OF THE PT JUST BELOW THE AREA OF THE EDA PATCH. THE TECHNICIAN ESTIMATED THAT THE EXTRAVASATION VOLUME WAS APPROXIMATELY 50-75ML. COLD COMPRESSES WERE APPLIED AND THE PT'S ARM WAS ELEVATED FOR A FEW HOURS. THE PT WAS RELEASED TO HOME AND NO FURTHER MEDICAL INTERVENTION WAS REQUIRED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other GAUGE SAFETY INTIMA ANGIOCATH.| ULTRAVIST 370 NON-IONIC CONTRAST BY ABBOTT, 20