BEUDAMED
    FDA Adverse Event Other Summary report: N

    EZEM PERCUPUMP CONTROL

    MDR report key: 261860 · Received February 9, 2000

    Report

    Report Number
    MW1018106
    Event Type
    Other
    Date Received
    February 9, 2000
    Date of Event
    January 5, 2000
    Report Date
    January 13, 2000
    Manufacturer
    E-Z-EM, INC.
    Product Code
    FIH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IA, US
    Reporter Occupation
    RADIOLOGIC TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    PT REFERRED TO RADIOLOGY FOR A CT SCAN OF THE CHEST WITH CONTRAST. A 20 GAUGE IV CATHETER WAS PLACED IN THE RIGHT ANTECUBITAL VEIN. A TEST DOSE OF 6CC WAS GIVEN WITH NO SWELLING NOTICED AND NO EXTRAVASATION ALARM. EXTRAVASATION INJECTION PATCH WAS PLACED ABOVE HUB OF IV CATHETER. INJECTION OF CONTRAST BEGUN AT A RATE OF 1.8CC/SEC AND A 45 SECOND DELAY. PT WAS INSTRUCTED TO NOTIFY STAFF IF ANY PAIN OCCURRED. SCANNING BEGAN BEFORE ALL CONTRAST WAS INJECTED. STAFF NOTED NO CONTRAST ENHANCEMENT AND CHECKED IV SITE. SWELLING NOTED. NO EXTRAVASATION ALARM OCCURRED. 140CC OF CONTRAST HAD BEEN POWER INJECTED. PHYSICIAN NOTIFIED. WARM PACKS WERE PLACED OVER EXTRAVASATION SITE FOR 10-15 MINS. PT WAS THEN DISCHARGED HOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EZEM PERCUPUMP CONTROL POWER INJECTOR FIH E-Z-EM, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other