BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERCUPUMP CT INJECTOR W/EDA

    MDR report key: 281719 · Received June 7, 2000

    Report

    Report Number
    2432460-2000-00019
    Event Type
    Malfunction
    Date Received
    June 7, 2000
    Date of Event
    April 21, 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 1.5CC/SEC AND THE INJECTION SITE WAS THE ANTECUBITAL FOSSA. AFTER INJECTING THE ENTIRE 150ML OF CONTRAST, THE TECHNOLOGIST NOTICED A LACK OF CONTRAST IN THE FIRST COMPUTERIZED TOMOGRAPHY (CT) IMAGES. THE CONTRAST HAD EXTRAVASATED AND LEAKED TO THE FOLDS OF THE SKIN BEHIND THE PT'S ELBOW. THERE WAS NO RAISED BUMP OR ANY SIGNS OF EXTRAVASATION DIRECTLY BENEATH THE EDA PATCH. THE CT SCAN WAS PERFORMED AS A NON-CONTRAST EXAM. PT WAS TREATED WITH WIDASE, COLD PACKS WERE APPLIED TO THE INJECTION SITE AND THE PT'S ARM WAS ELEVATED.

    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 UNKNOWN Other UNKNOWN).| CONRAY IONIC CONTRAST(TYPE OF ANGIOCATH IS