BEUDAMED
    FDA Adverse Event Death Summary report: N

    STELLANT DUAL CT SYSTEM

    MDR report key: 5353349 · Received January 8, 2016

    Report

    Report Number
    2520313-2016-00003
    Event Type
    Death
    Date Received
    January 8, 2016
    Date of Event
    December 15, 2015
    Report Date
    December 15, 2015
    Manufacturer
    BAYER MEDICAL CARE
    Product Code
    DXT
    PMA / PMN Number
    K082905
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BAYER SERVICE PERFORMED A SYSTEM CHECKOUT ON DECEMBER 16, 2015 AND FOUND THE SYSTEM WAS PERFORMING TO SPECIFICATION. THE SYSTEM HAS BEEN IN USE DAILY SINCE THE REPORTED OCCURRENCE. THE CUSTOMER DID NOT RETURN DISPOSABLES OR PROVIDE LOT NUMBERS; THEREFORE TESTING OF RETAINS IS UNABLE TO BE COMPLETED. IN THE EVENT THAT MORE INFORMATION IS RECEIVED A FOLLOW UP REPORT WILL BE SUBMITTED. THIS INFORMATION DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE, THE COMPANY OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THIS REPORTABLE EVENT.

    Description of Event or Problem · 1

    A BAYER REPRESENTATIVE REPORTED THE FOLLOWING: THE CUSTOMER STATED THAT A PATIENT EXPERIENCED A CONTRAST MEDIA REACTION WHEN ATTACHED TO THE STELLANT DX INJECTOR SYSTEM. POST PROCEDURE, WE RECEIVED INFORMATION THAT THE PATIENT SUFFERED A CARDIAC ARREST AND SUBSEQUENTLY EXPIRED; HOWEVER, THE EXACT TIME OF THE EVENTS IS UNKNOWN. THE NAME AND MANUFACTURER OF THE CONTRAST MEDIA HAS NOT BEEN PROVIDED. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION FROM THE SITE WITHOUT RESPONSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    13875 STELLANT DUAL CT SYSTEM CT INJECTION SYSTEM DXT BAYER MEDICAL CARE 3010432

    Patients

    Seq Age Sex Outcome Treatment
    1 Death