BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERCUPUMP CT INJECTOR W/EDA

    MDR report key: 289425 · Received August 8, 2000

    Report

    Report Number
    2432460-2000-00025
    Event Type
    Malfunction
    Date Received
    August 8, 2000
    Date of Event
    July 3, 2000
    Report Date
    July 5, 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 1.5CC/SEC, AND THE INJECTION SITE WAS THE ANTECUBITAL FOSSA. A TOTAL VOLUME OF 100CC'S/NON-IONIC CONTRAST WAS INJECTED AND EXTRAVASATED DEEP IN THE TISSUE WHICH THE EDA PATCH DID NOT DETECT. THE EXTRAVASATION WAS NOT UNDER THE AREA OF THE EDA PATCH AND IT WAS THE OPINION OF THE PHYSICIAN THAT IT TRAVELED POSTERIORLY. THE PT WAS TREATED WITH HOT COMPRESSES AND THE FAMILY PHYSICIAN WAS NOTIFIED. PT WAS A TRAUMA PT AND THE IV WAS ADMINISTERED OUTSIDE THE HOSP BY THE EMERGENCY MEDICAL TECHNICIAN. CT RN SAID THAT THE IV SEEMED TO BE FINE PRIOR TO THE INJECTION.

    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 21 YR Other JOHNSON AND JOHNSON "PROTECTIV" 18 GAUGE ANGIO-| CATH, ISOVU 300 NON-IONIC CONTRAST BY SQUIBB.