BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERCUPUMP CT INJECTOR W/EDA

    MDR report key: 281694 · Received June 7, 2000

    Report

    Report Number
    2432460-2000-00020
    Event Type
    Malfunction
    Date Received
    June 7, 2000
    Date of Event
    April 27, 2000
    Report Date
    May 11, 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 INJECTION FLOW RATE WAS SET FOR 1.5 CC/SEC. AND THE INJECTION SITE WAS THE ANTECUBITAL FOSSA. AT THE END OF THE EXAM (TOTAL OF 150ML OF CONTRAST INJECTED) AN EXTRAVASATION WAS NOTED ON THE PT'S FOREARM. THE EXTRAVASATION VOLUME WAS ESTIMATED TO BE APPROXIMATELY 3 INCHES BELOW THE AREA OF THE EDA PATCH. THE PT WAS TREATED WITH COLD PACKS AND THE ARM ELEVATED. NO FURTHER MEDICAL INTERVENTION WAS REQUIRED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other CONRAY IONIC CONTRAST (TYPE OF ANGIOCATH IS UNK).