BEUDAMED
    FDA Adverse Event Death Summary report: N

    STELLANT DUAL CT INJECTOR

    MDR report key: 14043035 · Received April 7, 2022

    Report

    Report Number
    2520313-2022-00014
    Event Type
    Death
    Date Received
    April 7, 2022
    Date of Event
    March 28, 2022
    Report Date
    April 7, 2022
    Manufacturer
    BAYER MEDICAL CARE, INC.
    Product Code
    DXT
    UDI-DI
    00616258008943
    PMA / PMN Number
    K082905
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A SYSTEM SERVICE CHECK OF THE MEDRAD® STELLANT CT INJECTION SYSTEM (SN (B)(4)), WAS COMPLETED BY BAYER SERVICE ON MARCH 31, 2022, WHICH CONFIRMED THAT THE INJECTOR WAS OPERATING WITHIN SPECIFICATION. THE DISPOSABLES THAT WERE IN USE DURING THE PROCEDURE WERE DISCARDED BY THE SITE AND LOT NUMBERS WERE UNABLE TO BE PROVIDED; THEREFORE, TESTING OF RETAINED SAMPLES IS UNABLE TO BE PERFORMED AT THIS TIME. AN OFFER FOR ADDITIONAL CLINICAL APPLICATIONS TRAINING HAS BEEN DECLINED BY THE CUSTOMER AT THIS TIME. 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

    THE FOLLOWING INFORMATION WAS REPORTED TO BAYER SERVICE. A (B)(6) FEMALE UNDERGOING A CT UROGRAM SUFFERED A MI (MYOCARDIAL INFARCTION) AND PASSED AWAY WHILE CONNECTED TO A MEDRAD® STELLANT CT INJECTION SYSTEM (SN (B)(4)). FOLLOWING THE CONTRAST INJECTION, THE PATIENT'S MEDICAL STATUS DECLINED. SHE SUFFERED RESPIRATORY DISTRESS AND SUBSEQUENT MI. THE EMERGENCY RESPONSE TEAM WAS CALLED AND LIFE SAVING MEASURES WERE INITIATED; HOWEVER THE PATIENT ULTIMATELY PASSED AWAY. THE CUSTOMER STATED THAT THE STAFF DO NOT ASSOCIATE THE USE OF THE INJECTOR TO BE INVOLVED WITH THE DEATH OF THE PATIENT. AN AUTOPSY STATEMENT HAS BEEN REQUESTED; HOWEVER ONE HAS NOT BEEN PROVIDED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1696189 STELLANT DUAL CT INJECTOR CT INJECTION SYSTEM DXT BAYER MEDICAL CARE, INC. 60726807 00616258008943

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female Death