BEUDAMED
    FDA Adverse Event Other Summary report: N

    ANGIOMAT CT9000 ADV INJECTOR

    MDR report key: 530646 · Received June 18, 2004

    Report

    Report Number
    1518293-2004-00008
    Event Type
    Other
    Date Received
    June 18, 2004
    Date of Event
    May 25, 2004
    Report Date
    May 27, 2004
    Manufacturer
    LIEBEL-FLARSHEIM CO.
    Product Code
    DXT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A PT UNDERWENT A CT CHEST, ABDOMEN, AND PELVIS. THE PT WAS PUT ON THE TABLE AROUND 10:30 AM AND AN IV WAS STARTED AND AN INJECTION OF 100CC OPTIRAY ADMINISTERED WITH A CT9000 FRONT-LOAD INJECTOR WITH OPTIBOLUS. AFTER THE PROCEDURE WAS COMPLETED THE PT WAS COMPLAINING OF FEELING FUNNY IN THEIR CHEST. TWO RADIOLOGISTS CAME TO THE ROOM AND MONITORED THE PT. BOTH OBSERVED BLOOD PRESSURE AND HEART RATE, WHICH WERE WITHIN NORMAL LIMITS (BP 136/72, HR 94). A BLOOD GLUCOSE STRIP WAS TESTED AND IT WAS 168. ULTIMATELY THE PT WAS PUT IN INPATIENT HOLDING AND MONITORED BY THE SPECIAL PROCEDURES DEPARTMENT. AFTER THE TIME IN INPATIENT HOLDING, ALL VITALS WERE CONTINUOUSLY FINE AND PT WAS CLEARED TO GO HOME. LATER DURING THE DAY AFTER THE SCAN WAS READ, IT WAS DISCOVERED THAT AIR WAS FOUND AROUND THE HEART. AIR ESTIMIATED TO BE 30-60CC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANGIOMAT CT9000 ADV INJECTOR ANGIOGRAPHIC INJECTOR & SYRINGE DXT LIEBEL-FLARSHEIM CO. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Hospitalization