BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CT EXPRES

    MDR report key: 20126587 · Received September 3, 2024

    Report

    Report Number
    3004753774-2024-00003
    Event Type
    Injury
    Date Received
    September 3, 2024
    Date of Event
    April 17, 2024
    Report Date
    September 3, 2024
    Manufacturer
    BRACCO INJENEERING S.A.
    Product Code
    IZQ
    PMA / PMN Number
    K151048
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3: THE CT EXPRES 3D INJECTION SYSTEM, SERIAL NUMBER (B)(6), WAS RETURNED FOR EVALUATION ON 16 AUGUST 2024, BUT THE INVESTIGATION HAS NOT YET BEEN COMPLETED. ALTHOUGH REQUESTED, THE CT EXPRES CONSUMABLE KITS USED DURING THE EVENT ARE NOT AVAILABLE FOR EVALUATION; THESE ITEMS WERE DISCARDED BY THE CUSTOMER. THE LOT NUMBERS OF THE CONSUMABLES USED WERE NOT PROVIDED OR NOT KNOWN. THE CT EXPRES INJECTION SYSTEM USED DURING THE EVENT HAS BEEN RETURNED, BUT THE EVALUATION IS NOT YET COMPLETE. THE INJECTION SYSTEM WILL BE FUNCTIONALLY TESTED AND A REVIEW OF THE DEVICE HISTORY RECORDS AND SERVICE HISTORY WILL BE PERFORMED. UPON COMPLETION OF THE INVESTIGATION, A FINAL REPORT WILL BE SUBMITTED TO THE UNITED STATES FOOD AND DRUG ADMINISTRATION (FDA).

    Additional Manufacturer Narrative · 0

    H3: THE CT EXPRÈS 3D INJECTION SYSTEM, SERIAL NUMBER (B)(6), WAS RETURNED FOR EVALUATION ON 16 AUGUST 2024. THE INJECTION SYSTEM WAS FUNCTIONALLY TESTED AND MET THE PRE-ESTABLISHED SPECIFICATIONS. ALTHOUGH REQUESTED, THE CT EXPRÈS CONSUMABLE KITS USED DURING THE EVENT ARE NOT AVAILABLE FOR EVALUATION; THESE ITEMS WERE DISCARDED BY THE CUSTOMER. THE LOT NUMBERS OF THE CONSUMABLES USED WERE NOT PROVIDED OR NOT KNOWN. A REVIEW OF THE DEVICE HISTORY RECORD AND COMPLAINT HISTORY WAS COMPLETED FOR THE CT EXPRÈS 3D INJECTION SYSTEM, SERIAL NUMBER (B)(6). THE REVIEWS CONFIRMED THERE WERE NO ISSUES RELATED TO THE REPORTED EVENT. PER THE CT EXPRÈS 3D CONTRAST MEDIA DELIVERY SYSTEM OPERATOR MANUAL, "EXTRAVASATION IS HAZARDOUS, IN PARTICULAR WITH CONTRAST MEDIA, AND CAN RESULT IN SERIOUS INJURIES. THE FOLLOWING CONDITIONS CAN RESULT IN EXTRAVASATION AND MUST BE AVOIDED: HIGH FLOW RATES DURING VENOUS INJECTION WITH VENOUS ACCESS NOT PROPERLY SECURED AGAINST DISLODGING DURING INJECTION, MISPLACEMENT WITHIN THE PATIENT'S VEIN, AND WEAKNESS OF, OR LEAKAGE AT, THE CATHETERIZED VEIN. DURING THE INJECTION, MONITOR THE PATIENT FOR SIGNS OF EXTRAVASATION. IF EXTRAVASATION IS SUSPECTED OR OCCURS, STOP THE INJECTION IMMEDIATELY AND DISCONNECT THE PATIENT FROM THE CT EXPRÈS¿ 3D. REMOVE THE INTRAVENOUS NEEDLE. TREAT THE EXTRAVASATION AS PER THE STANDARDS OF PRACTICE IN YOUR CLINICAL AREA." IN SUMMARY, TESTING OF THE CT EXPRÈS INJECTION SYSTEM FOUND NO EVIDENCE OF DEVICE MALFUNCTION RELATED TO THE INJECTION SYSTEM. EVALUATION OF THE EVENT, BASED ON THE AVAILABLE INFORMATION, WAS UNABLE TO CONFIRM A DEVICE MALFUNCTION ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 0

    ON (B)(6) 2024, DURING A COMPUTED TOMOGRAPHY (CT) SCAN WITH A CT EXPRES INJECTION SYSTEM, THE MALE PATIENT EXPERIENCED AN EXTRAVASATION OF AN UNKNOWN AMOUNT OF CONTRAST MEDIA. PRIOR TO THE INJECTION, THE PATIENT'S CANNULA WAS FLUSHED WITH SALINE AND NO ISSUES WERE NOTED. DURING THE BEGINNING OF THE CONTRAST PHASE OF THE INJECTION, THE PATIENT EXPERIENCED DISCOMFORT WHICH TURNED INTO SEVERE PAIN. THE RADIOGRAPHERS STOPPED THE INJECTION AND THE PATIENT WAS SENT TO THE EMERGENCY DEPARTMENT A FEW HOURS LATER FOR DECOMPRESSION OF COMPARTMENT SYNDROME AND WAS NOTED TO HAVE SUFFERED MAJOR HARM DUE TO NECROSIS OF MUSCLE TISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1369767 CT EXPRES CT CONTRAST MEDIUM INJECTION SYSTEM, LINE-POWERED, STATIONARY IZQ BRACCO INJENEERING S.A. 3D

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Male Other OMNIPAQUE 350 CONTRAST MEDIA| PRO SAFETY NEEDLE PROTECTED IV CANNULA 20G BD