BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERCUPUMP CT INJECTOR WITH EDA

    MDR report key: 285580 · Received July 10, 2000

    Report

    Report Number
    2432460-2000-00024
    Event Type
    Malfunction
    Date Received
    July 10, 2000
    Date of Event
    June 8, 2000
    Report Date
    June 8, 2000
    Manufacturer
    E-Z-EM, INC.
    Product Code
    FIH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE UNIT WAS PROGRAMMED TO INJECT 100ML OF CONTRAST AT A FLOW RATE OF 2.1CC/SEC. THE LOCATION OF THE ANGIOCATH WAS THE RIGHT ANTECUBITAL FOSSA. AT 69ML, THE INJECTOR PAUSED TO CHECK FOR EXTRAVASATION. EXAMINATION OF THE INJECTION SITE BY THE TECHNICIAN CONFIRMED AN EXTRAVASATION DIRECTLY UNDER THE AREA OF THE PATCH. THERE WAS NO CONTRAST ENHANCEMENT ON THE IMAGES INDICATING THAT ALL 69CC'S OF CONTRAST EXTRAVASATED. THE PT WAS TREATED WITH ICE PACKS AND CONSULTED BY A PLASTIC SURGEON. PT WAS THEN RELEASED TO HOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERCUPUMP CT INJECTOR WITH EDA CT INJECTOR EXTRAVASATION ACCESSORY FIH E-Z-EM, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other 22 GAUGE ANGIOCATH MFG BY BECTON DICKENSON.| OMNIPAQUE 300 NON-IONIC CONTRAST MFG BY NYCOMED,