BEUDAMED
    FDA Adverse Event Death Summary report: N

    STELLANT DUAL CT INJECTOR

    MDR report key: 5587402 · Received April 20, 2016

    Report

    Report Number
    2520313-2016-00023
    Event Type
    Death
    Date Received
    April 20, 2016
    Date of Event
    March 21, 2016
    Report Date
    March 22, 2016
    Manufacturer
    BAYER MEDICAL CARE, INC.
    Product Code
    DXT
    PMA / PMN Number
    K082905
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BAYER SERVICE PERFORMED A SYSTEM SERVICE CHECK OF THE INJECTOR AND FOUND IT TO BE OPERATING TO SPECIFICATION.

    Additional Manufacturer Narrative · 1

    THE DISPOSABLES USED DURING THIS EVENT WERE DISCARDED AT THE SITE; HOWEVER, THE SITE WAS ABLE TO PROVIDE THE LOT NUMBERS. BAYER PRODUCT ANALYSIS WILL BE TESTING RETAINED SAMPLES. BAYER SERVICE WILL PERFORM A CHECK ON THE INJECTOR AS SOON AS IT CAN BE ARRANGED WITH THE SITE. THIS INVESTIGATION REMAINS IN PROGRESS AND A FOLLOW UP REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    THE SITE REPORTED THE FOLLOWING: A (B)(6) MALE PATIENT WAS UNDERGOING A CT SCAN OF THE ABDOMEN IN A DIAGNOSTIC CLINIC FOR SUSPECTED SPLENOMEGALY. HE COMPLAINED OF NOT FEELING WELL 5 MINUTES AFTER AN INTRAVENOUS INJECTION OF 100ML OF CONTRAST MEDIA USING A STELLANT D INJECTION SYSTEM, SERIAL NUMBER (B)(4). CONTRAST MEDIA WAS VISUALIZED AND NO AIR WAS DETECTED ON THE FINAL CT IMAGES. POST INJECTION, THE PATIENT REPORTEDLY SUFFERED A LOSS OF MOTOR STRENGTH, AGITATION WITH TYPICAL SEIZURE MOVEMENTS, CUTANEOUS PALLOR, DYSPNEA AND THORACIC PAIN ASSOCIATED WITH RESPIRATORY DIFFICULTY. THE PATIENT REMAINED CONSCIOUS FOR A SHORT PERIOD FOLLOWED BY A LACK OF CAROTID PULSE, APNEA AND CARDIO-RESPIRATORY ARREST. ADVANCED CARDIOVASCULAR LIFE SUPPORT (ACLS) PROTOCOLS WERE PERFORMED AND THE PATIENT WAS RESUSCITATED. WHILE HE WAS IN ROUTE TO BE TRANSFERRED BY AMBULANCE TO A LOCAL HOSPITAL HIS CONDITION DETERIORATED AND HE EXPIRED. THE PATIENT WAS REPORTED TO HAVE A HISTORY OF EPILEPSY AND THE CAUSE OF DEATH WAS REPORTED AS ACUTE MYOCARDIAL INFARCTION. THE SITE CONTINUES TO USE THE INVOLVED INJECTOR AND HAVE REPORTED NO PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    245372 STELLANT DUAL CT INJECTOR CT INJECTION SYSTEM DXT BAYER MEDICAL CARE, INC. 3007301

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Death