BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CT EXPRES

    MDR report key: 24941246 · Received April 21, 2026

    Report

    Report Number
    3004753774-2026-00003
    Event Type
    Injury
    Date Received
    April 21, 2026
    Date of Event
    March 12, 2026
    Report Date
    April 20, 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 EXPRES 3D INJECTOR SYSTEM, SERIAL NUMBER (B)(6), HAS BEEN REQUESTED FOR EVALUATION BY THE BRACCO MEDICAL TECHNOLOGIES / ACIST EUROPE SERVICE CENTER. THE CT EXPRES DAY SET, LOT NUMBER UNKNOWN, AND THE CT EXPRES PATIENT SET, LOT NUMBER UNKNOWN, ARE EXPECTED TO BE RETURNED FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION, BRACCO MEDICAL TECHNOLOGIES, INC., WILL SUBMIT THE RESULTS AND CONCLUSIONS OF THE EVENT. BRACCO MEDICAL TECHNOLOGIES' MEDICAL ADVISORY BOARD MEMBER PROVIDED THE FOLLOWING CLINICAL EVALUATION OF THE EVENT: IT HAS BEEN WELL DOCUMENTED THAT VOLUMES OF AIR INJECTED INTRAVENOUSLY GREATER THAN 25 CC HAVE THE POTENTIAL FOR SERIOUS HARM, PERMANENT DISABILITY, OR DEATH WHEREAS VOLUMES LESS THAN 10 CC IN ADULTS ARE CONSIDERED ESSENTIALLY SAFE. BASED ON THE DESCRIPTION OF THE AIR BUBBLES AND THE SCAN IMAGE, THE VOLUME OF AIR ADMINISTERED WAS LESS THAN 5 CC. AS NOTED ABOVE, THIS VOLUME OF AIR WOULD NOT BE EXPECTED TO CAUSE PATIENT HARM. THE TRANSFER OF THE PATIENT TO ANOTHER HOSPITAL FOR HYPERBARIC TREATMENT IS CONSIDERED UNNECESSARY. THIS ADVERSE EVENT IS CONSIDERED NON-SERIOUS AND EXPECTED.

    Description of Event or Problem · 0

    A 43-YEAR-OLD FEMALE PATIENT PRESENTED FOR A HEAD CT SCAN TO CHECK FOR POSSIBLE RETROPHARYNGEAL ABSCESS. THE SCAN WAS INITIATED WITHOUT INCIDENT; HOWEVER, DURING THE INJECTION OF CONTRAST MEDIA USING THE CT EXPRES INJECTOR SYSTEM, THE CT EXPRES INJECTOR SYSTEM STOPPED, AND THE USER HAD TO RESTART IT. THE SCAN PROTOCOL WAS COMPLETED, AND THE SCAN WAS OF DIAGNOSTIC QUALITY. UPON SUBSEQUENT REVIEW OF THE IMAGES BY THE RADIOLOGIST, AIR WAS NOTED IN THE RIGHT SUBCLAVIAN VEIN AND THE PROXIMAL PART OF THE RIGHT JUGULAR VEIN. THERE WAS ONE (1) LARGE BUBBLE WITH A DIAMETER OF 7 MM 7.5 MM AND THREE (3) ADDITIONAL TINY BUBBLES. THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL FOR HYPERBARIC CHAMBER TREATMENT. THE PATIENT WAS ASYMPTOMATIC DURING THE CT EXAMINATION, DURING THE TRANSFER TO THE OTHER HOSPITAL, AND DURING AND AFTER THE HYPERBARIC TREATMENT. A DIAGNOSIS OF AIR EMBOLISM WAS MADE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1003894 CT EXPRES CT CONTRAST MEDIUM INJECTION SYSTEM, LINE-POWERED, STATIONARY IZQ BRACCO INJENEERING S.A. 3D

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Female Hospitalization CLEMIS 370 MG/ML 500ML CONTRAST (LOT : PY1428°)