BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERCUPUMP TOUCHSCREEN INJECTOR SYSTEM W/EDA

    MDR report key: 370661 · Received January 4, 2002

    Report

    Report Number
    2432460-2002-00001
    Event Type
    Malfunction
    Date Received
    January 4, 2002
    Date of Event
    December 4, 2001
    Report Date
    December 5, 2001
    Manufacturer
    E-Z-EM, INC.
    Product Code
    FIH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INJECTOR WAS SET TO INJECT 140 ML'S OF CONTRAST IN THE ANTECUBITAL FOSSA AT A FLOW RATE OF 3.0 CC/SEC. APPROXIMATELY 100 ML'S OF CONTAST EXTRAVASATED IN THE PATIENT'S LEFT ARM. PATIENT WAS TREATED WITH WARM COMPRESSES, ARM WAS ELEVATED. PATIENT'S PHYSICIAN WAS NOTIFIED OF OCCURRENCE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other ISOVUE NON-IONIC CONTRAST, TYPE OF ANGIOCATH NOT| KNOWN.