BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STELLANT DUAL CT INJECTOR

    MDR report key: 22494387 · Received July 14, 2025

    Report

    Report Number
    2520313-2025-00017
    Event Type
    Injury
    Date Received
    July 14, 2025
    Date of Event
    June 16, 2025
    Report Date
    July 14, 2025
    Manufacturer
    BAYER MEDICAL CARE INC.
    Product Code
    DXT
    UDI-DI
    00616258020792
    PMA / PMN Number
    K192370
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A SYSTEM SERVICE CHECK OF THE MEDRAD® STELLANT FLEX CT INJECTOR, SERIAL NUMBER (B)(6), WAS COMPLETED ON JUNE 17, 2025 WHICH CONFIRMED THAT THE INJECTOR WAS OPERATING WITHIN BAYER SPECIFICATIONS. MULTIPLE DOCUMENTED ATTEMPTS HAVE BEEN MADE TO GAIN SPECIFIC INFORMATION RELATED TO THE REPORTED EVENT, INCLUDING THE DISPOSABLES INVOLVED; HOWEVER, THESE ATTEMPTS HAVE BEEN UNSUCCESSFUL. IN THE EVENT THAT ADDITIONAL INFORMATION IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED. THE MEDRAD® STELLANT FLEX CT INJECTION SYSTEM OPERATION MANUAL CAUTIONS THE USER AS FOLLOWS: WARNING: AIR EMBOLISM HAZARD - SERIOUS PATIENT INJURY OR DEATH MAY RESULT. ENSURE PATIENT IS NOT CONNECTED WHILE PURGING AIR FROM SYRINGE OR ENGAGING OR ADVANCING PLUNGER. EXPEL ALL TRAPPED AIR FROM THE SYRINGE(S), CONNECTORS, TUBING, AND CATHETER BEFORE CONNECTING THE SYSTEM TO THE PATIENT. 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. THIS INFORMATION DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE, THE COMPANY OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO A REPORTABLE EVENT.

    Description of Event or Problem · 0

    BAYER MEDICAL CARE WAS NOTIFIED OF AN ALLEGED AIR INJECTION THAT HAD OCCURRED DURING A CT SCAN WHILE A PATIENT WAS CONNECTED TO A MEDRAD® STELLANT FLEX CT INJECTION SYSTEM (SERIAL NUMBER (B)(6)). FOLLOWING THE INJECTION, AN UNDISCLOSED AMOUNT OF AIR WAS VISUALIZED ON THE DISPLAYED IMAGES. THE PATIENT WAS REPORTED TO HAVE BEEN TRANSFERRED TO ANOTHER FACILITY AND THEIR CURRENT STATUS IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    856007 STELLANT DUAL CT INJECTOR CT INJECTION SYSTEM DXT BAYER MEDICAL CARE INC. 85631829 00616258020792

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| O