BEUDAMED
    FDA Adverse Event Death Summary report: N

    STELLANT DUAL CT INJECTOR

    MDR report key: 12933516 · Received December 6, 2021

    Report

    Report Number
    2520313-2021-00049
    Event Type
    Death
    Date Received
    December 6, 2021
    Date of Event
    November 6, 2021
    Report Date
    December 6, 2021
    Manufacturer
    BAYER MEDICAL CARE INC.
    Product Code
    DXT
    PMA / PMN Number
    K082905
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    A SYSTEM SERVICE CHECK OF THE STELLANT CT INJECTION SYSTEM, SERIAL NUMBER (B)(4), WAS COMPLETED ON (B)(6) 2021 WHICH CONFIRMED THAT THE INJECTOR WAS OPERATING WITHIN BAYER SPECIFICATIONS. THE DISPOSABLES THAT WERE IN USE DURING THE PROCEDURE WERE DISCARDED BY THE SITE; HOWEVER, THE CUSTOMER WAS ABLE TO PROVIDE A LOT NUMBER FOR THE STELLANT CT DISPOSABLE KIT. BAYER PRODUCT ANALYSIS RECEIVED AND EXAMINED A RETAINED SDS-CTP-SPK DISPOSABLE KIT, LOT NUMBER 8601709. FUNCTIONAL TESTING CONCLUDED THAT THE DISPOSABLES PERFORMED TO SPECIFICATION WITH NO PROBLEMS OBSERVED. THE OFFER OF ADDITIONAL CLINICAL APPLICATIONS TRAINING HAS BEEN ACCEPTED BY THE CUSTOMER AND IS SCHEDULED FOR (B)(6) 2021. 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. A (B)(6) FEMALE PATIENT EXPERIENCING DIFFICULTY BREATHING UNDERWENT A COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) OF THE CHEST TO RULE OUT A PULMONARY EMBOLISM (PE) WHILE CONNECTED TO A STELLANT CT INJECTION SYSTEM (SERIAL NUMBER (B)(4)). UPON REVIEW OF THE DISPLAYED IMAGES, THE CUSTOMER DESCRIBED A SIGNIFICANT VOLUME OF AIR VISUALIZED WITHIN THE RIGHT ATRIUM EXTENDING TO THE MAIN PULMONARY TRUNK AND BILATERAL MAIN PULMONARY ARTERIES. THE CUSTOMER STATED TO BAYER IN A PHONE INTERVIEW THAT HE DID NOT THINK THE INJECTOR NOR DISPOSABLES WERE AT FAULT BUT NEEDED TO HAVE IT CHECKED OUT PER THEIR HOSPITAL QUALITY TEAM REQUIREMENTS. THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU) WITH APPROPRIATE CONSULTS MADE. AN IMMEDIATE SEARCH COMMENCED FOR THE PATIENT TO BE TRANSFERRED TO A FACILITY WITH HYPERBARIC CAPABILITIES. THE FAMILY MET AND DISCUSSED THE PROGNOSIS AND OPTED TO PLACE THEIR LOVED ONE INTO PALLIATIVE CARE FOR COMFORT UNTIL HER DEATH. NO AUTOPSY WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1832256 STELLANT DUAL CT INJECTOR CT INJECTION SYSTEM DXT BAYER MEDICAL CARE INC. 81058881

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female Death DISPOSABLE KIT: SDS-CTP-SPK - LOT 8601709