BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CT9000 ADV DOMESTIC BASIC SYS

    MDR report key: 670769 · Received February 2, 2006

    Report

    Report Number
    1518293-2006-00001
    Event Type
    Injury
    Date Received
    February 2, 2006
    Date of Event
    December 6, 2005
    Report Date
    January 3, 2006
    Manufacturer
    LIEBEL-FLARSHEIM CO.
    Product Code
    DXT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT HAVING CT DONE. WHEN CONTRAST INJECTION BEGAN, PATIENT BEGAN TO EXPERIENCE CHEST PAIN. BENEDRYL GIVEN FOR POSSIBLE REACTION TO CONTRAST. WHEN IMAGES REVIEWED NO CONTRAST MEDIA WAS SEEN; ARTIFACT WAS NOTED IN HEART. REVIEW OF EVENT DETERMINED THAT AIR MAY HAVE BEEN INJECTED INSTEAD OF CONTRAST. PATIENT WAS DISCHARGED THE NEXT DAY. INJECTOR WILL CONTINUE TO WORK EVEN IF NO CONTRAST MEDIA IS IN THE SYRINGE. CONTRAST MEDIA IS A CLEAR SOLUTION. CIRCLE ON INJECTOR SYRINGE WHICH CHANGES TO OVAL WHEN SYRINGE IS FULL IS HARD TO VISUALIZE. IV ACCESS WAS GAINED THRU THE LEFT AC WITH A 22G CATHALON DEVICE. THE INJECTOR SYRINGE WAS CONNECTED VIA TYPICAL COILED TUBING. INJECTOR PROTOCOL WAS SET FOR 2.5ML RATE FOR A 150ML VOLUME OF CONTRAST MEDIA. CONTRAST MEDIA INJECTION AND SCAN PROCEDURE COMPLETED. TECHNOLOGIST WENT TO CHECK ON PT POST PROCEDURE AND PT DESCRIBE CHEST PAIN AND SOB. RADIOLOGIST SUMMONDED AND BENADRYL WAS GIVEN. FIV MINUTES LATER THE NURSE WAS CALLED FOR WITH VITAL SIGN MONITORING EQUIPMENT. PT WAS THEN ADMITTED TO HOSPITAL ICU FOR OBSERVATION, RELEASED THE NEXT DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CT9000 ADV DOMESTIC BASIC SYS ANGIOGRAPHIC POWER INJECTOR DXT LIEBEL-FLARSHEIM CO. CT9000ADV NA

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Hospitalization