BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERCUPUMP CT INJECTOR WITH EDA

    MDR report key: 291720 · Received August 17, 2000

    Report

    Report Number
    2432460-2000-00026
    Event Type
    Malfunction
    Date Received
    August 17, 2000
    Date of Event
    July 11, 2000
    Report Date
    July 12, 2000
    Manufacturer
    E-Z-EM, INC.
    Product Code
    FIH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE INJECTOR WAS SET TO INJECT A TOTAL VOLUME OF 143ML OF CONTRAST IN ANTECUBITAL FOSSA. IT WAS REPORTED THAT THE CONTRAST WAS VISIBLE AFTER INJECTION AND, UPON EXAMINING THE PT, AN EXTRAVASATION OF APPROXIMATELY 135CC WAS OBSERVED. THE EXTRAVASATION WAS UNIFORMLY SPREAD OUT FROM THE WRIST TO THE ELBOW AND WAS HARD AND FIRM (BLOOD FLOW WAS NOT RESTRICTED). THE PT DID NOT COMPLAIN OF PAIN AND NO REDNESS WAS NOTED. PT WAS TREATED WITH ICE AND THE ARM WAS KEPT ELEVATED. PT WAS KEPT IN THE DEPT FOR APPROXIMATELY 1 HOUR FOR OBSERVATION.

    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 UNKNOWN Other 1. OMNIPAQUE 300 NON-IONIC CONTRAST MFG BY NYCOMED| 2. 22 GAUGE CATHETER BY JELCO.