BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CENTARGO CT INJECTOR

    MDR report key: 22922651 · Received August 29, 2025

    Report

    Report Number
    2520313-2025-00022
    Event Type
    Injury
    Date Received
    August 29, 2025
    Date of Event
    August 4, 2025
    Report Date
    August 29, 2025
    Manufacturer
    IMAXEON PTY LTD
    Product Code
    DXT
    UDI-DI
    09345390001123
    PMA / PMN Number
    K241849
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    A SYSTEM SERVICE CHECK OF THE MEDRAD® CENTARGO CT INJECTION SYSTEM, SERIAL NUMBER (B)(6), WAS PERFORMED ON (B)(6) 2025, WHICH CONFIRMED THAT THE INJECTOR WAS OPERATING WITHIN BAYER SPECIFICATIONS. THE DISPOSABLES THAT WERE IN USE DURING THE PROCEDURE WERE DISCARDED BY THE CUSTOMER; HOWEVER, THE LOT NUMBER OF THE DAY SET (CENT-DS, LOT NUMBER 1491372001) AND PATIENT LINE (CENT-PL, LOT NUMBER 243110) WERE PROVIDED. FUNCTIONAL TESTING OF RETAINED SAMPLES FROM CENT-DS, LOT NUMBER 1491372001 AND CENT-PL, LOT NUMBER 243110 CONCLUDED THAT THE RETAINED DISPOSABLES PERFORMED TO SPECIFICATION WITH NO PROBLEMS OBSERVED. THE OFFER OF ADDITIONAL CLINICAL APPLICATIONS TRAINING WAS DECLINED BY THE CUSTOMER. THE MEDRAD® CENTARGO CT INJECTION SYSTEM OPERATION MANUAL CAUTIONS 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. 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. 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 INC. WAS INFORMED THAT A FEMALE UNDERGOING A CARDIAC CT SCAN EXPERIENCED AN ALLEGED AIR INJECTION WHILE CONNECTED TO A MEDRAD® CENTARGO CT INJECTION SYSTEM (SN (B)(6)). FOLLOWING THE INJECTION, THE CUSTOMER HAD REPORTED SEEING 3 AIR BUBBLES ON THE DISPLAYED IMAGES WITHIN THE RIGHT ATRIUM AND RIGHT VENTRICLE. THE PATIENT FELT DIZZY AFTER THE PROCEDURE AND HAD UNDERGONE AN ECHOCARDIOGRAPHY ULTRASOUND TO EVALUATE THE AIR EMBOLISM. THE PATIENT WAS DISCHARGED THE SAME DAY WITH NO FURTHER ISSUES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2886787 CENTARGO CT INJECTOR CT INJECTION SYSTEM DXT IMAXEON PTY LTD 87381390 09345390001123

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other DAY SET - LOT 1491372001.| PATIENT LINE - LOT 243110.