BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CENTARGO CT INJECTOR

    MDR report key: 23289982 · Received October 15, 2025

    Report

    Report Number
    2520313-2025-00025
    Event Type
    Injury
    Date Received
    October 15, 2025
    Date of Event
    August 14, 2025
    Report Date
    November 3, 2025
    Manufacturer
    IMAXEON PTY LTD
    Product Code
    DXT
    UDI-DI
    09345390002366
    PMA / PMN Number
    K241849
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A SYSTEM SERVICE CHECK OF THE MEDRAD® CENTARGO CT INJECTION SYSTEM (SN (B)(6) HAS BEEN REQUESTED AND WE ARE AWAITING THE RESULTS. THE DISPOSABLES THAT WERE IN USE DURING THE ALLEGED INCIDENT WERE DISCARDED BY THE SITE AND THE LOT NUMBERS WERE NOT PROVIDED; THEREFORE, TESTING OF RETAINED SAMPLES WAS NOT POSSIBLE. ONCE THE INVESTIGATION IS COMPLETED, A FOLLOW-UP REPORT WILL BE SUBMITTED. THE CUSTOMER HAS ACCEPTED THE OFFER OF ADDITIONAL CLINICAL APPLICATIONS TRAINING WHICH WILL BE SCHEDULED. THE MEDRAD® CENTARGO CT INJECTION SYSTEM OPERATION MANUAL CAUTIONS THE USER AS FOLLOWS: WARNING: AIR EMBOLISM HAZARD - SERIOUS PATIENT INJURY OR DEATH MAY RESULT. DO NOT MODIFY OR ATTEMPT TO CIRCUMVENT THE OPERATION OF THE AIR DETECTORS. DO NOT CONNECT THE PATIENT LINE TO THE PATIENT UNTIL ALL TRAPPED AIR HAS BEEN CLEARED. THE MEDRAD® CENTARGO CT INJECTION SYSTEM OPERATION MANUAL ALSO DIRECTS THE USER AS FOLLOWS: THE SYSTEM MUST BE ARMED PRIOR TO PERFORMING ANY INJECTION IN A PROTOCOL. PRESS ARM TO ARM THE SYSTEM. FOR THE FIRST INJECTION OF AN EXAM, A MESSAGE DISPLAYS ASKING FOR CONFIRMATION THE PATIENT LINE HAS BEEN CHECKED FOR AIR. PRESS YES TO CONFIRM ALL AIR HAS BEEN EXPELLED AND NO AIR IS VISIBLE IN THE PATIENT LINE. PRESS NO IF THE PATIENT LINE HAS NOT BEEN CHECKED FOR AIR. THE SYSTEM WILL NOT ARM. THIS INFORMATION DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE, THE COMPANY, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO A REPORTABLE EVENT.

    Additional Manufacturer Narrative · 0

    A SYSTEM SERVICE CHECK OF THE MEDRAD® CENTARGO CT INJECTION SYSTEM, SERIAL NUMBER (B)(6), WAS COMPLETED ON SEPTEMBER 26, 2025 WHICH CONFIRMED THAT THE INJECTOR WAS OPERATING WITHIN BAYER SPECIFICATIONS. THE DISPOSABLES THAT WERE IN USE DURING THE ALLEGED INCIDENT WERE DISCARDED BY THE SITE AND THE LOT NUMBERS WERE NOT PROVIDED; THEREFORE, TESTING OF RETAINED SAMPLES WAS NOT POSSIBLE. A REVIEW OF THE SYSTEM LOG FILE REVEALED THAT, JUST PRIOR TO THE AIR INJECTION, THE USER HAD INSERTED A NEW DAY SET WHICH INITIATED THE START-OF-DAY PROCESS WHICH TAKES MORE TIME TO INITIATE DUE TO THE SYSTEMS PROACTIVE AIR PURGE SEQUENCE AND AUTOMATIC DAY SET PRIMING VIA VACUUM AIR REMOVAL, COMPARED TO WHEN A PATIENT LINE IS REPLACED BETWEEN PATIENTS OR PROCEDURES. THE INTERVAL BETWEEN THE COMPLETION OF THE START-OF-DAY PROCESS AND THE INJECTOR BEING ARMED WAS RELATIVELY SHORT IN DURATION, RESULTING IN A SIGNIFICANTLY HIGH PRIME PRESSURE. THIS WOULD BE AN INDICATION THAT THE START OF DAY PROCESS WAS LIKELY STILL IN PROGRESS WHEN THE PATIENT'S IV CATHETER WAS CONNECTED. AS MENTIONED IN THE MEDRAD® CENTARGO OPERATION MANUAL: A "RED" LIGHT DISPLAY SIGNIFIES NOT TO CONNECT TO A PATIENT, SINCE EITHER (1) THE DAY SET IS PURGING AIR OR (2) THE INSTALLED PATIENT LINE IS NOT PRIMED. ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER CONFIRMED THAT THE USER DID NOT FOLLOW PROCEDURE TO ENSURE THAT THERE WAS NO AIR IN THE TUBING. THE OFFER OF ADDITIONAL CLINICAL APPLICATIONS TRAINING HAS BEEN ACCEPTED BY THE CUSTOMER AND WILL BE SCHEDULED. THE MEDRAD® CENTARGO CT INJECTION SYSTEM OPERATION MANUAL AND PATIENT LINE INSTRUCTIONS FOR USE (IFU) CAUTIONS THE USER TO CONFIRM THAT ALL AIR HAS BEEN REMOVED FROM THE PATIENT LINE PRIOR TO CONNECTING TO A PATIENT. ADDITIONALLY, THE USER NEEDS TO MANUALLY ACKNOWLEDGE THE CHECK FOR AIR POP UP ON THE SYSTEM DISPLAY BEFORE INJECTION. IN THIS INCIDENT, IN ORDER TO ARM THE INJECTOR, THE TECHNOLOGIST WOULD HAVE NEEDED TO CONFIRM THE CHECK FOR AIR POPUP BEFORE THE INJECTION BUT MAY HAVE NEGLECTED TO VISUALLY CHECK FOR AIR IN THE PATIENT LINE. THE MEDRAD® CENTARGO CT INJECTION SYSTEM OPERATION MANUAL CAUTIONS THE USER AS FOLLOWS: WARNING: AIR EMBOLISM HAZARD - SERIOUS PATIENT INJURY OR DEATH MAY RESULT. DO NOT MODIFY OR ATTEMPT TO CIRCUMVENT THE OPERATION OF THE AIR DETECTORS. DO NOT CONNECT THE PATIENT LINE TO THE PATIENT UNTIL ALL TRAPPED AIR HAS BEEN CLEARED. THE MEDRAD® CENTARGO CT INJECTION SYSTEM OPERATION MANUAL ALSO DIRECTS THE USER AS FOLLOWS: THE SYSTEM MUST BE ARMED PRIOR TO PERFORMING ANY INJECTION IN A PROTOCOL. PRESS ARM TO ARM THE SYSTEM. FOR THE FIRST INJECTION OF AN EXAM, A MESSAGE DISPLAYS ASKING FOR CONFIRMATION THE PATIENT LINE HAS BEEN CHECKED FOR AIR. PRESS YES TO CONFIRM ALL AIR HAS BEEN EXPELLED AND NO AIR IS VISIBLE IN THE PATIENT LINE. PRESS NO IF THE PATIENT LINE HAS NOT BEEN CHECKED FOR AIR. THE SYSTEM WILL NOT ARM. 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 THE PATIENT WAS CONNECTED TO A MEDRAD® CENTARGO CT INJECTION SYSTEM (SERIAL NUMBER (B)(6). FOLLOWING THE INJECTION, APPROXIMATELY 10-15ML OF AIR WAS VISUALIZED ON THE DISPLAYED IMAGES. ALTHOUGH THE PATIENT WAS ASYMPTOMATIC THROUGHOUT THE EXAMINATION, THE PATIENT WAS PLACED IN A LEFT SIDE DOWN DECUBITUS POSITION. THE PATIENT WAS OBSERVED FOR 10 MINUTES POST PROCEDURE AND SUBSEQUENTLY UNDERWENT A REPEAT CT SCAN WHICH CONFIRMED THAT THE AIR HAD RESOLVED. NO FURTHER ISSUES WERE REPORTED.

    Description of Event or Problem · 0

    BAYER MEDICAL CARE WAS NOTIFIED OF AN ALLEGED AIR INJECTION THAT HAD OCCURRED DURING A CT SCAN WHILE THE PATIENT WAS CONNECTED TO A MEDRAD® CENTARGO CT INJECTION SYSTEM (SERIAL NUMBER (B)(6)). FOLLOWING THE INJECTION, APPROXIMATELY 10-15 ML OF AIR WAS VISUALIZED ON THE DISPLAYED IMAGES. ALTHOUGH THE PATIENT WAS ASYMPTOMATIC THROUGHOUT THE EXAMINATION, THE PATIENT WAS PLACED IN A LEFT SIDE DOWN DECUBITUS POSITION. THE PATIENT WAS OBSERVED FOR 10 MINUTES POST PROCEDURE AND SUBSEQUENTLY UNDERWENT A REPEAT CT SCAN WHICH CONFIRMED THAT THE AIR HAD RESOLVED. NO FURTHER ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2790827 CENTARGO CT INJECTOR CT INJECTION SYSTEM DXT IMAXEON PTY LTD 88628624 09345390002366

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other CENT-DS - LOT NUMBER UNKNOWN| CENT-PL - LOT NUMBER UNKNOWN