BEUDAMED
    FDA Adverse Event Death Summary report: N

    STELLANT DUAL CT INJECTOR

    MDR report key: 4027629 · Received August 4, 2014

    Report

    Report Number
    2520313-2014-00041
    Event Type
    Death
    Date Received
    August 4, 2014
    Date of Event
    July 10, 2014
    Report Date
    July 11, 2014
    Manufacturer
    BAYER MEDICAL CARE, INC.
    Product Code
    DXT
    PMA / PMN Number
    K082905
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A BAYER FIELD SERVICE ENGINEER PERFORMED A SYSTEM SERVICE CHECKOUT OF THE STELLANT D INJECTOR SYSTEM, SERIAL NUMBER (B)(4) ON (B)(6) 2014 AND THE UNIT WAS FOUND TO BE OPERATING TO SPECIFICATION. THE DISPOSABLES FROM THE ALLEGED INCIDENT WERE DISCARDED AND NOT AVAILABLE FOR EVALUATION. FUNCTIONAL TESTING OF THE RETAINED LOT NUMBERS PROVIDED BY THE SITE FOUND THE DISPOSABLES PERFORMED TO SPECIFICATION. THE STELLANT D INJECTOR HAS BEEN IN USE DAILY AT THE SITE SINCE THIS OCCURRENCE WITHOUT ANY ADDITIONAL REPORTED ISSUES. ADDITIONAL APPLICATIONS TRAINING WAS DESIRED BY THE CUSTOMER AND WILL BE SCHEDULED IN THE NEAR FUTURE.

    Description of Event or Problem · 1

    THE SITE REPORTED THE FOLLOWING TO A BAYER R AND I REPRESENTATIVE: A FEMALE PT EXPIRED AFTER UNDERGOING A CT SCAN OF THE CHEST FOR SUSPECTED PULMONARY EMBOLISM. FOLLOWING THE CONTRAST INJECTION, THE RADIOLOGIST OBSERVED THAT THERE WAS NO CONTRAST ON THE FINAL IMAGES. THE STAFF DETERMINED THAT THEY ATTACHED THE DISPOSABLES INCORRECTLY AND INSTEAD THE CONTRAST HAD SPILLED ONTO THE FLOOR. THE INJECTOR SYSTEM WAS PREPARED ONCE AGAIN AND UPON COMPLETION OF THE INJECTION, THE HEALTHCARE PROFESSIONAL VISUALIZED AIR IN THE PT'S RIGHT VENTRICLE OF THE HEART ON THE FINAL CT IMAGES. POST PROCEDURE, THE PT WAS TAKEN TO THE INTENSIVE CARE WHERE SHE DIED LATER THAT NIGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    455553 STELLANT DUAL CT INJECTOR CT INJECTION SYSTEM DXT BAYER MEDICAL CARE, INC. 3007301

    Patients

    Seq Age Sex Outcome Treatment
    1 Death