BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDRAD® CENTARGO CT INJECTOR

    MDR report key: 24618128 · Received March 17, 2026

    Report

    Report Number
    2520313-2026-00010
    Event Type
    Injury
    Date Received
    March 17, 2026
    Date of Event
    February 27, 2026
    Report Date
    April 15, 2026
    Manufacturer
    IMAXEON PTY LTD
    Product Code
    DXT
    UDI-DI
    09345390002915
    PMA / PMN Number
    K241849
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A SYSTEM SERVICE CHECK OF THE MEDRAD® CENTARGO CT INJECTOR (SN (B)(6)) WAS COMPLETED ON MARCH 5, 2026, BY A BAYER SERVICE REPRESENTATIVE, WHO CONFIRMED THAT THE INJECTOR WAS OPERATING WITHIN SPECIFICATIONS. BAYER SERVICE IS CURRENTLY EVALUATING LOG FILES FROM THE INJECTOR SYSTEM FROM THE TIME OF ALLEGATION. BAYER CLINICAL SUPPORT PROVIDED FOLLOW UP TRAINING ON MARCH 4, 2026, AT THE CUSTOMER'S REQUEST. THIS INVESTIGATION REMAINS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A FOLLOW-UP REPORT WILL BE SUBMITTED. 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 A CONTRAST ADMINISTRATION INCIDENT THAT OCCURRED ON (B)(6) 2026, DURING A CT RUNOFF EXAMINATION AT THE CUSTOMER'S SITE WHILE THE MEDRAD® CENTARGO CT INJECTOR SYSTEM WAS IN USE. DESPITE THE PATIENT'S INITIAL INTRAVENOUS ACCESS BEING NOTED BY THE TECHNOLOGIST AS SUBOPTIMAL, THE INJECTION WAS STILL INITIATED. EARLY IN THE CONTRAST PHASE, THE IV BECAME INTERSTITIAL, RESULTING IN APPROXIMATELY 111 ML OF CONTRAST EXTRAVASATING INTO THE SURROUNDING TISSUE. ACQUIRED CT IMAGES DEMONSTRATED NO INTRAVASCULAR ENHANCEMENT, AND THE INJECTION WAS HALTED DURING THE POST-CONTRAST SALINE PHASE. A NEW INTRAVENOUS CATHETER WAS ESTABLISHED, AND THE TECHNOLOGIST ATTEMPTED TO REIMAGE THE PATIENT. ACCORDING TO THE CUSTOMER'S EMAIL, WHEN THE INJECTOR WAS ACTIVATED, AN ADDITIONAL BOLUS OF CONTRAST WAS DELIVERED. A SECOND TECHNOLOGIST IDENTIFIED THAT A TEST SALINE INJECTION WAS NOT PERFORMED FIRST, AND THE CONTRAST INJECTION WAS STOPPED AFTER APPROXIMATELY 66 ML HAD BEEN ADMINISTERED. A FULL REPEAT INJECTION OF 111 ML WAS LATER PERFORMED TO OBTAIN DIAGNOSTIC IMAGES. IN TOTAL, THE PATIENT RECEIVED APPROXIMATELY 288 ML OF CONTRAST ACROSS THE THREE INJECTION ATTEMPTS. THE PATIENT WAS SUBSEQUENTLY DIAGNOSED WITH CONTRAST-RELATED ACUTE KIDNEY INJURY ATTRIBUTED TO THE TOTAL CONTRAST VOLUME ADMINISTERED. THE STATUS OF THE PATIENT IS UNKNOWN AT THIS TIME. AN INTERNAL INVESTIGATION IS BEING CONDUCTED AT THE CUSTOMER SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    677827 MEDRAD® CENTARGO CT INJECTOR CT INJECTION SYSTEM DXT IMAXEON PTY LTD 88982797 09345390002915

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other OMNIPAQUE 350.GE GLOBAL REFERENCE #: (B)(4).