BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERCUPUMP CT INJECTOR W/EDA

    MDR report key: 277625 · Received May 10, 2000

    Report

    Report Number
    2432460-2000-00015
    Event Type
    Malfunction
    Date Received
    May 10, 2000
    Date of Event
    April 10, 2000
    Report Date
    April 10, 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

    THE INJECTOR FLOW RATE WAS SET FOR 3.0 CC/SEC AND THE INJECTION SITE WAS THE ANTECUBITAL FOSSA. THE TOTAL INJECTION VOLUME WAS SET FOR 145 ML. AT THE BEGINNING OF THE EXAM, AN EXTRAVASATION (ESTIMATED TO BE APPROXIMATELY 30 CC'S) OCCURRED WHICH THE EDA DID NOT DETECT. THE PT WAS TREATED WITH WARM COMPRESSES. NO FURTHER MEDICAL INTERVENTION WAS REQUIRED.

    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 82 YR Other CATHETER BY BECTON DICKENSON.| BERUEX ULTRAVIST NON-IONIC CONTRAST, 20 GAUGE