BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STELLANT DUAL CT INJECTOR

    MDR report key: 16981279 · Received May 22, 2023

    Report

    Report Number
    2520313-2023-00012
    Event Type
    Injury
    Date Received
    May 22, 2023
    Date of Event
    April 21, 2023
    Report Date
    May 22, 2023
    Manufacturer
    BAYER MEDICAL CARE INC.
    Product Code
    DXT
    PMA / PMN Number
    K082905
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A SYSTEM SERVICE CHECK OF THE STELLANT CT INJECTOR, SERIAL NUMBER (B)(6), WAS COMPLETED ON (B)(6) 2023, WHICH CONFIRMED THAT THE INJECTOR WAS OPERATING WITHIN BAYER SPECIFICATIONS. THERE WAS NO EVIDENCE OF EQUIPMENT MALFUNCTION. THE CUSTOMER DISCARDED THE SUSPECT DISPOSABLES AT THE TIME OF THE INCIDENT; HOWEVER, THEY WERE ABLE TO PROVIDE A LOT NUMBER FOR THE STELLANT DISPOSABLE KIT. BAYER PRODUCT ANALYSIS EVALUATED A RETAIN SAMPLE FROM STELLANT CT DISPOSABLE SDS-CTP-SPK, LOT NUMBER 8627374. NO VISUAL OR FUNCTIONAL DEFECTS WERE IDENTIFIED. FUNCTIONAL TESTING CONCLUDED THAT THE RETAINED DISPOSABLES PERFORMED TO SPECIFICATION WITH NO PROBLEMS OBSERVED. ADDITIONAL APPLICATIONS TRAINING WAS OFFERED; HOWEVER, THE CUSTOMER DECLINED. 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

    BAYER MEDICAL CARE INC. WAS NOTIFIED OF AN ALLEGED AIR INJECTION THAT HAD OCCURRED DURING A CT SCAN WHILE THE PATIENT WAS CONNECTED TO A MEDRAD® STELLANT CT INJECTION SYSTEM (SERIAL NUMBER (B)(6)). FOLLOWING THE INJECTION, APPROXIMATELY 30-50ML OF AIR WAS VISUALIZED ON THE DISPLAYED IMAGES. THE PATIENT WAS REPORTED TO HAVE SUFFERED A SEIZURE AFTER THE CONTRAST INJECTION WAS COMPLETED AND WAS SUBSEQUENTLY TRANSFERRED TO AN INTENSIVE CARE UNIT (ICU) AT ANOTHER FACILITY FOR FURTHER CARE. THE PATIENT WAS REPORTED TO BE DOING BETTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    849094 STELLANT DUAL CT INJECTOR CT INJECTION SYSTEM DXT BAYER MEDICAL CARE INC. 58746456

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female Other| H SDS-CTP-SPK - LOT NUMBER 8627374.