BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CT EXPRES

    MDR report key: 24552353 · Received March 9, 2026

    Report

    Report Number
    3004753774-2026-00002
    Event Type
    Injury
    Date Received
    March 9, 2026
    Date of Event
    February 6, 2026
    Report Date
    March 9, 2026
    Manufacturer
    BRACCO INJENEERING S.A.
    Product Code
    IZQ
    PMA / PMN Number
    K151048
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CT EXPRÈS EVO INJECTOR SYSTEM CE INJECTOR SERIAL NUMBER (B)(6), HAS BEEN REQUESTED TO BE RETURNED TO THE BRACCO/ACIST EUROPE SERVICE CENTER FOR EVALUATION. THE CONSUMABLE KITS USED DURING THE EVENT WILL BE RETURNED FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION, BRACCO MEDICAL TECHNOLOGIES (BMT) WILL SUBMIT THE RESULTS AND CONCLUSIONS OF THE EVENT. THE BMT MEDICAL ADVISORY BOARD MEMBER REVIEWED THE INFORMATION PROVIDED BY THE USER FACILITY AND PROVIDED THE FOLLOWING CLINICAL EVALUATION OF THE EVENT: A FEMALE PATIENT OF UNREPORTED AGE PRESENTED FOR A CT ANGIOGRAM OF THE SUPRA-AORTIC TRUNK. NO MEDICAL HISTORY, REASON FOR THE SCAN, OR SCAN PARAMETERS WERE PROVIDED. THE OMNIPAQUE CONTRAST MEDIA WAS ADMINISTERED, BUT THE STRENGTH WAS NOT PROVIDED. THE SCAN WAS INITIATED WITHOUT INCIDENT; HOWEVER, DURING THE INJECTION, THE TECHNICIAN NOTICED THE PRESENCE OF AIR ON THE CT IMAGES AND IMMEDIATELY STOPPED THE INJECTION. IT APPEARS THAT WHILE THE VIAL CONTAINED CONTRAST AGENT, THE TUBING RESERVOIR WAS EMPTY, EXPLAINING THE AIR INJECTION. IT WAS REPORTED BY THE USER THAT THE CT EXPRÈS EVO INJECTOR SYSTEM DID NOT DETECT THE PRESENCE OF AIR IN THE TUBING. THERE WERE NO PROBLEMS WITH THE PREVIOUS PATIENT USING THE SAME LINE/VIAL. THE PATIENT WAS TRANSFERRED TO A FACILITY IN LILLE FRANCE FOR HYPERBARIC OXYGEN THERAPY. THERE WAS NO REPORT OF THE PATIENT HAVING ANY SYMPTOMS OR BEING IN DISTRESS. A DIAGNOSIS OF AIR EMBOLISM WAS MADE.

    Description of Event or Problem · 0

    A CT SCAN WAS PERFORMED ON A PATIENT, USING THE CT EXPRÈS EVO INJECTOR SYSTEM TO INJECT CONTRAST MEDIA. AT THE TIME OF THE EVENT, THE LEFT VIAL ON THE CT EXPRÈS EVO INJECTOR SYSTEM WAS 50% FILLED WITH CONTRAST MEDIA AND THE RIGHT VIAL WAS 100% FILLED WITH CONTRAST MEDIA. DURING AN INJECTION OF CONTRAST MEDIA INTO THE PATIENT, THE TECHNICIAN NOTICED THE PRESENCE OF AIR ON THE CT IMAGES AND IMMEDIATELY STOPPED THE INJECTION. IT WAS NOTED THAT THERE WAS NO ALERT FROM CT EXPRES INJECTOR OF THE PRESENCE OF AIR IN THE TUBING. WHILE THE VIAL CONTAINED CONTRAST AGENT, THE TUBING RESERVOIR WAS EMPTY; THIS IS THE ASSUMED CAUSE OF THE AIR INJECTION. THERE HAD BEEN NO PROBLEMS WITH THE PREVIOUS PATIENT USING THE SAME LINE/VIAL. AFTER THE AIR INJECTION WAS NOTED, THE PATIENT WAS TRANSFERRED TO A FACILITY IN LILLE, FRANCE FOR HYPERBARIC OXYGEN THERAPY. THE PATIENT IS SUBSEQUENTLY REPORTED TO BE HEALTHY AND FULLY RECOVERED BUT HAD BEEN UNDER OBSERVATION AFTER THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    74936 CT EXPRES CT CONTRAST MEDIUM INJECTION SYSTEM, LINE-POWERED, STATIONARY IZQ BRACCO INJENEERING S.A. CT EXPRÈS EVO INJECTOR SYSTEM CE

    Patients

    Seq Age Sex Outcome Treatment
    1