BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERCUPUMP CT INJECTOR WITH EDA

    MDR report key: 291709 · Received August 17, 2000

    Report

    Report Number
    2432460-2000-00027
    Event Type
    Malfunction
    Date Received
    August 17, 2000
    Date of Event
    July 12, 2000
    Report Date
    July 13, 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 WAS SET TO INJECT A TOTAL VOLUME OF 100ML OF CONTRAST IN THE ANTECUBITAL FOSSA AT A FLOW RATE OF 1.5CC/SEC. AN EXTRAVASATION, ESTIMATED TO BE APPROXIMATELY 93ML, OCCURRED THAT THE EDA DID NOT DETECT. THE EXTRAVASATION WENT UP THE ARM AND MAY HAVE BEEN DEEP IN THE MUSCLE. PT WAS ADMITTED TO THE HOSPITAL AND HEAT PACKS WERE APPLIED TO THE AREA.

    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 71 YR Hospitalization| O 1. ISOVU 300 NON-IONIC CONTRAST MFG BY SQUIBB,| 2. 22 GAUGE ANIOCATH MFG BY BECTON DICKINSON.