BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STELLANT DUAL CT INJECTOR

    MDR report key: 11678082 · Received April 16, 2021

    Report

    Report Number
    2520313-2021-00012
    Event Type
    Injury
    Date Received
    April 16, 2021
    Date of Event
    April 7, 2021
    Report Date
    April 16, 2021
    Manufacturer
    BAYER MEDICAL CARE, INC.
    Product Code
    DXT
    PMA / PMN Number
    K082905
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BAYER SERVICE VISITED THE CUSTOMER SITE AND PERFORMED A SYSTEM CHECKOUT. THE INJECTOR WAS FOUND TO PERFORM TO SPECIFICATIONS. THE CUSTOMER PROVIDED INFORMATION THAT NON-BAYER DISPOSABLES WERE USED DURING THE INCIDENT; THEREFORE, TESTING IS NOT POSSIBLE. ADDITIONAL APPLICATIONS TRAINING WAS OFFERED AND ACCEPTED BY THE CUSTOMER. A BAYER CLINICAL SUPPORT SPECIALIST WILL SCHEDULE TRAINING WITH THE CUSTOMER. THE MEDRAD® STELLANT CT INJECTION SYSTEM OPERATION MANUAL INSTRUCTS THAT OPERATOR VIGILANCE AND CARE, COUPLED WITH A SET PROCEDURE, IS ESSENTIAL TO MINIMIZING THE POSSIBILITY OF AN AIR EMBOLISM. IN ADDITION, THE OPERATION MANUAL PROVIDES THE FOLLOWING WARNINGS AND CAUTIONS. PATIENT INJURY OR DEATH COULD RESULT FROM AN AIR EMBOLISM. EXPEL ALL TRAPPED AIR FROM THE SYRINGE(S), CONNECTORS, TUBING, AND CATHETER-OVER-NEEDLE BEFORE CONNECTING THE SYSTEM TO THE PATIENT. CAREFULLY READ THE INSTRUCTIONS FOR LOADING AND THE USE OF FLUIDOT® INDICATORS (WHERE APPLICABLE) TO REDUCE THE CHANCE OF AIR EMBOLI. PATIENT INJURY COULD RESULT FROM USING IMPROPER ACCESSORIES. USE ONLY ACCESSORIES AND OPTIONS PROVIDED BY MEDRAD DESIGNED FOR THIS SYSTEM. TO MINIMIZE AIR EMBOLIZATION RISKS, ENSURE THAT ONE OPERATOR IS DESIGNATED THE RESPONSIBILITY OF FILLING THE SYRINGE(S). DO NOT CHANGE OPERATORS DURING THE PROCEDURE. IF AN OPERATOR CHANGE MUST OCCUR, ENSURE THAT THE NEW OPERATOR VERIFIES THAT THE FLUID PATH IS PURGED OF AIR. FOR PROPER OPERATION, USE ONLY ACCESSORIES AND OPTIONS PROVIDED BY MEDRAD THAT ARE DESIGNED SPECIFICALLY FOR THE SYSTEM. OTHER NON-MEDRAD APPROVED ACCESSORIES OR OPTIONS MAY CAUSE EQUIPMENT DAMAGE OR MAY RESULT IN INCREASED EMISSIONS OR DECREASED IMMUNITY OF THE SYSTEM. ADDITIONALLY, THE OPERATION MANUAL PROVIDES THE FOLLOWING USER INSTRUCTION, "CAREFULLY INSPECT ALL TUBING AND SYRINGES, AND VERIFY THAT ALL AIR HAS BEEN EXPELLED FROM THE FLUID PATH BEFORE PRESSING CHECK FOR AIR".

    Description of Event or Problem · 1

    THE SITE REPORTED THE FOLLOWING: AN (B)(6)-YEAR-OLD MALE PATIENT HAD UNDERGONE A CT SCAN OF THE ABDOMEN / PELVIS WITH INTRAVENOUS CONTRAST INJECTION WHILE CONNECTED TO A MEDRAD® STELLANT CT INJECTION SYSTEM. THE SITE REPORTED THAT THERE WAS A "PATIENT INCIDENT ASSOCIATED WITH A LARGE AIR EMBOLISM IMMEDIATELY AFTER AN IV CONTRAST STUDY WAS CONDUCTED WITH A BAYER INJECTOR". THE EXACT AMOUNT AND ANATOMICAL LOCATION OF THE ALLEGED AIR WAS NOT DISCLOSED. A CODE BLUE WAS INITIATED FOR THE PATIENT IMMEDIATELY FOLLOWING THE INCIDENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED; HOWEVER, THE SITE HAS DECLINED TO RELEASE FURTHER DETAILS AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    574423 STELLANT DUAL CT INJECTOR CT INJECTION SYSTEM DXT BAYER MEDICAL CARE, INC. 58746456

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention