BEUDAMED
    FDA Adverse Event Death Summary report: N

    STELLANT DUAL INJECTOR

    MDR report key: 2967793 · Received February 13, 2013

    Report

    Report Number
    2520313-2013-00007
    Event Type
    Death
    Date Received
    February 13, 2013
    Date of Event
    January 15, 2013
    Report Date
    January 16, 2013
    Manufacturer
    MEDRAD, INC.
    Product Code
    DXT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE SITE, THE FOLLOWING ACTIONS WERE TAKEN; THE STELLANT D INJECTOR WAS PLACED IN QUARANTINE FOLLOWING THE REPORTED INCIDENT. THE SITE CALLED IN A THIRD PARTY TO CONDUCT AN INVESTIGATION CONCERNING ALL TREATMENT AND TESTING THAT WAS PERFORMED ON THE PATIENT. THE SITE REPORTED THAT THE THIRD PARTY DETERMINED THAT THE INJECTOR WAS WORKING WITHIN SPECIFICATION. SUBSEQUENTLY, THE STELLANT D INJECTOR SYSTEM WAS RELEASED BACK INTO USE ON (B)(4) 2013 BY THE SITE. BAYER R AND I SERVICE PERFORMED A SYSTEM SERVICE CHECKOUT OF THE INJECTOR ON (B)(4) 2013 AND DETERMINED IT TO BE OPERATING WITHIN SPECIFICATION. ALTHOUGH THE ACTUAL DISPOSABLES INVOLVED AT THE TIME OF THE REPORTED EVENT WERE DISCARDED, THE SITE WAS ABLE TO PROVIDE A LOT NUMBER OF THE STELLANT SYRINGE KIT THAT WAS USED DURING THE PROCEDURE. BAYER R AND I TESTED A RETAINED SAMPLE FROM LOT NUMBER 134918. FUNCTIONAL TESTING OF THE RETAINED DISPOSABLE DETERMINED THAT IT PERFORMED TO SPECIFICATION. ADDITIONAL APPLICATIONS TRAINING HAS BEEN ACCEPTED BY THE SITE. THE DATE OF THE FOLLOW UP TRAINING IS STILL BEING DETERMINED. THIS INFORMATION DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE, THE COMPANY OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO A REPORTABLE EVENT.

    Description of Event or Problem · 1

    THE CT/MRI SUPERVISOR AT THE SITE REPORTED THE FOLLOWING: A (B)(6) MALE PATIENT WITH A HISTORY OF HYPOTENSION AND MYELODYSPLASIA WAS ADMITTED TO THE EMERGENCY DEPARTMENT WITH A DIAGNOSIS OF MESENTERIC INFARCTION. THE PATIENT HAD A POWER PORT PLACED IN THE RIGHT UPPER CHEST FOR INTRAVENOUS ACCESS. HE UNDERWENT A CT SCAN OF THE ABDOMEN AND PELVIS WITH CONTRAST FOR ABDOMINAL PAIN. THE CT SCAN WAS COMPLETED WITHOUT EVENT AT 17:41. THE RADIOLOGIST IDENTIFIED AORTIC THROMBUS AS WELL AS AN INDETERMINATE AMOUNT OF AIR IN THE CARDIAC REGION ON THE FINAL CT IMAGES. THE RADIOLOGIST NOTIFIED THE EMERGENCY DEPARTMENT AT 18:30 WITH HIS FINDINGS. THE PATIENT WAS THEN PLACED IN TRENDELENBURG POSITION AND ON HIS LEFT SIDE IN THE EMERGENCY DEPARTMENT. THE PATIENT SUFFERED A CARDIAC ARREST AND DID NOT RECOVER. THE DOCUMENTED TIME OF DEATH WAS 19:45.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    62355 STELLANT DUAL INJECTOR CT INJECTION SYSTEM DXT MEDRAD, INC. 3007301

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Death STELLANT SYRINGE KIT SDS-CTP-SPK, LOT# 134918