BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CT EXPRES

    MDR report key: 17826427 · Received September 27, 2023

    Report

    Report Number
    3004753774-2023-00004
    Event Type
    Injury
    Date Received
    September 27, 2023
    Date of Event
    March 10, 2023
    Report Date
    September 26, 2023
    Manufacturer
    BRACCO INJENEERING S.A.
    Product Code
    IZQ
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G4: THE CT EXPRES INJECTION SYSTEM, MODEL 4D, IS NOT APPROVED FOR USE IN THE UNITED STATES. HOWEVER, A SIMILAR DEVICE, THE CT EXPRES INJECTION SYSTEM, MODEL 3D, IS APPROVED FOR USE IN THE UNITED STATES (510K: K071378), THEREFORE THIS EVENT IS BEING REPORTED TO FDA. H3: THE CT EXPRES INJECTION SYSTEM, SERIAL NUMBER (B)(6), WAS EVALUATED BY A BRACCO IMAGING SCANDINAVIA'S THIRD-PARTY SERVICE PROVIDER ON (B)(6) 2023. THE INJECTION SYSTEM WAS FUNCTIONALLY TESTED AND MET PRE-ESTABLISHED SPECIFICATIONS. THE DOWNLOADED LOG FILES FROM THE CT EXPRES INJECTION SYSTEM REVIEWED BY A BRACCO MEDICAL TECHNOLOGIES QUALITY ENGINEER ON (B)(6) 2023. THIS REVIEW CONFIRMED THAT ON THE DATE OF THE EVENT ((B)(6) 2023), THE CT EXPRES INJECTION SYSTEM PERFORMED SIX (6) INJECTIONS WITHOUT AN ISSUE. SUBSEQUENT TO THE SIX (6) INJECTIONS COMPLETED WITHOUT ISSUE, THREE (3) ADDITIONAL INJECTIONS WERE PERFORMED DURING WHICH THE ALERT "OCCLUSION DETECTED" WAS DISPLAYED ON THE CT EXPRES INJECTION SYSTEM. THE USER CONTINUED USING THE CT EXPRES INJECTION SYSTEM AND THREE (3) ADDITIONAL INJECTIONS WERE SUBSEQUENTLY PERFORMED BY THE USER ON THE SAME DAY WITH NO ISSUES. ALTHOUGH REQUESTED, THE CT EXPRES CONSUMABLE KITS USED DURING THE EVENT WERE NOT AVAILABLE FOR EVALUATION AS THEY HAD BEEN DISCARDED BY THE USER FACILITY. THE LOT NUMBERS OF THE CONSUMABLES USED WERE NOT PROVIDED OR WERE NOT KNOWN. THE CT EXPRÈSTM 4D CONTRAST MEDIA DELIVERY SYSTEM OPERATOR MANUAL, SECTION 6, PROVIDES TROUBLESHOOTING STEPS TO BE TAKEN IF AN INJECTION IS INTERRUPTED BY AN OCCLUSION ALERT. IN SUMMARY, TESTING OF THE CT EXPRES 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. PER THE USER FACILITY, ALTHOUGH NO ACUTE HARM CAME TO THE PATIENT, THE INABILITY TO COMPLETE THE SCAN HAD THE POTENTIAL TO CAUSE SERIOUS PATIENT HARM AND MAY HAVE SIGNIFICANTLY COMPLICATED THE PATIENT'S TREATMENT.

    Description of Event or Problem · 0

    AN INTENSIVE CARE PATIENT ON A VENTILATOR, UNDERWENT A PULMONARY VASCULAR IMAGING PROCEDURE FOR PULMONARY EMBOLISM DIAGNOSIS, USING THE CT EXPRES INJECTION SYSTEM. INTRAVENOUS ACCESS VIA A PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) WAS USED FOR THE FIRST TWO CONTRAST INJECTIONS ATTEMPTS, WHICH WERE NOT COMPLETED DUE TO A BLOCKAGE OF FLOW INDICATED BY AN ALERT MESSAGE DISPLAYED ON THE CT EXPRES INJECTION SYSTEM. THE FUNCTION OF THE CATHETER WAS CAREFULLY CHECKED BY THE ATTENDING PHYSICIAN WITH NO ISSUES NOTED. PRIOR TO THE THIRD ATTEMPTED CONTRAST INJECTION, THE CT EXPRES CONTRAST BOTTLES AND TUBING WERE REPLACED AND THE PATIENT WAS FITTED WITH A NEW PERIPHERAL VENOUS CANNULA, THE FUNCTION OF WHICH WAS CHECKED BEFORE STARTING THE THIRD ATTEMPT TO INJECT CONTRAST WITH NO ISSUES NOTED. THE THIRD CONTRAST INJECTION WAS NOT COMPLETED DUE TO BLOCKAGE OF FLOW, AGAIN INDICATED BY AN ALERT MESSAGE ON THE CT EXPRES INJECTION SYSTEM DISPLAY. THE PHYSICIAN MADE THE DECISION TO NOT CONTINUE WITH THE IMAGING PROCEDURE AND THE PATIENT WAS RETURNED TO THE ICU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    776382 CT EXPRES CT CONTRAST MEDIUM INJECTION SYSTEM, LINE-POWERED, STATIONARY IZQ BRACCO INJENEERING S.A. 4D

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other 16 GAUGE CANNULA.| 18 GAUGE CANNULA.| OMNIPAQUE 350.| PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) LINE.