BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERCUPUMP CT INJECTOR W/EDA

    MDR report key: 277648 · Received May 10, 2000

    Report

    Report Number
    2432460-2000-00016
    Event Type
    Malfunction
    Date Received
    May 10, 2000
    Date of Event
    April 11, 2000
    Report Date
    April 11, 2000
    Manufacturer
    E-Z-EM, INC.
    Product Code
    FIH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INJECTION FLOW RATE WAS SET FOR 3.0 CC/SEC AND THE INJECTION SITE WAS THE ANTECUBITAL FOSSA. AN EXTRAVASATION (ESTIMATED TO BE 150 ML) EXTRAVASATED UNDER THE AREA OF THE PATCH WHICH THE EDA DID NOT DETECT. PT WAS TREATED WITH COLD COMPRESSES AND OBSERVED. NO FURTHER MEDICAL INTERVENTION WAS REQUIRED AND THE PT WAS RELEASED.

    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 72 YR Other GAUGE JELCO CATHETER BY BECTON DICKENSON.| OMNIPAQUE 300 NON-IONIC CONTRAST BY NYCOMED, 20