BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERCUPUMP CT INJECTOR W/EDA

    MDR report key: 285054 · Received June 29, 2000

    Report

    Report Number
    2432460-2000-00023
    Event Type
    Malfunction
    Date Received
    June 29, 2000
    Date of Event
    June 5, 2000
    Report Date
    June 5, 2000
    Manufacturer
    E-Z-EM, INC.
    Product Code
    FIH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INJECTOR WAS SET TO INJECT 100ML. OF CONTRAST AT A FLOW RATE OF 1.5ML/SEC., AND THE LOCATION OF THE ANGIOCATH WAS THE ANTECUBITAL FOSSA. AN EXTRAVASATION (ESTIMATED TO BE APPROXIMATELY 93ML) OCCURRED UNDERNEATH THE AREA OF THE PATCH WITHOUT THE SYSTEM ALARMING. THE PT WAS TREATED WITH ICE AND WARM PACKS, ELEVATION, AND MONITORING CALLS FOR TWO WEEKS POST.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other OMNIPAQUE NON-IONIC CONTRAST MANUFACTURED BY| NYCOMED, BECTON DICKENSON ANGIOCATH (SIZE NOT| KNOWN).