BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CT EXPRES

    MDR report key: 23186403 · Received September 30, 2025

    Report

    Report Number
    3004753774-2025-00005
    Event Type
    Injury
    Date Received
    September 30, 2025
    Date of Event
    September 2, 2025
    Report Date
    September 30, 2025
    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 INJECTION SYSTEM, SERIAL NUMBER (B)(6), WAS FUNCTIONALLY TESTED AND MET THE PRE-ESTABLISHED SPECIFICATIONS. THERE WAS NO EVIDENCE OF DEVICE MALFUNCTION RELATED TO THE REPORTED EVENT. THE INSTRUCTIONS FOR USE HAVE BEEN REVIEWED AND NO INADEQUACIES WERE IDENTIFIED REGARDING WARNINGS, CONTRAINDICATIONS, AND THE DIRECTIONS/CONDITIONS FOR USE OF THE DEVICE. BASED ON THE TESTING AND EVALUATION OF THE CT EXPRÈS INJECTION SYSTEM, THERE WAS NO EVIDENCE OF DEVICE MALFUNCTION RELATED TO THE EVENT. THE CONSUMABLES USED DURING THE CASE WERE DISCARDED BY THE USER FACILITY AND THE LOT NUMBERS ARE UNKNOWN. THE INFORMATION PROVIDED BY THE USER FACILITY WAS REVIEWED BY BRACCO'S MEDICAL ADVISOR AND THIS CLINICAL ASSESSMENT IS AS FOLLOWS: IT HAS BEEN WELL ESTABLISHED 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. THERE IS A VAST SAFETY DIFFERENCE BETWEEN AIR ADMINISTERED INTRA-VENOUSLY (IV) AND AIR ADMINISTERED INTRA-ARTERIALLY AND THE EXTREMELY REMOTE RISK OF HARM TO THE PATIENT FROM A 1 CC IV AIR ADMINISTRATION. BASED ON THE AMOUNT OF AIR ADMINISTERED INTRAVENOUSLY IT PRESENTED AN EXTREMELY REMOTE RISK TO THE PATIENT. THIS REPORT IS CLOSED.

    Description of Event or Problem · 0

    AFTER UNDERGOING A CORONARY CT SCAN, A 60-YEAR-OLD FEMALE PATIENT WAS RETURNED TO HER ROOM AND WAS ASYMPTOMATIC. TEN MINUTES LATER, THE RADIOLOGIST INFORMED THE SENIOR PHYSICIAN BY PHONE OF THE PRESENCE OF A FEW AIR BUBBLES (APPROXIMATELY 1 CC) IN THE PATIENT'S RIGHT HEART CHAMBERS, PULMONARY TRUNK, AND SUPERIOR VENA CAVA. A DIAGNOSIS OF AIR EMBOLISM WAS MADE. THE PHYSICIAN CALLED THE EMERGENCY DEPARTMENT FOR IMMEDIATE TRANSFER OF THE PATIENT FOR MONITORING. THE PATIENT WAS RE-PERFUSED AND PLACED ON OXYGEN. THE PATIENT UNDERWENT A HYPERBARIC CHAMBER SESSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2014241 CT EXPRES CT CONTRAST MEDIUM INJECTION SYSTEM, LINE-POWERED, STATIONARY IZQ BRACCO INJENEERING S.A. CT EXPRES 3D

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Female Hospitalization