BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STELLANT DUAL CT INJECTOR

    MDR report key: 19681041 · Received July 5, 2024

    Report

    Report Number
    2520313-2024-00013
    Event Type
    Injury
    Date Received
    July 5, 2024
    Date of Event
    June 11, 2024
    Report Date
    October 1, 2024
    Manufacturer
    BAYER MEDICAL CARE INC
    Product Code
    DXT
    UDI-DI
    00616258011219
    PMA / PMN Number
    K192370
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A SYSTEM SERVICE CHECK OF THE MEDRAD® STELLANT FLEX CT INJECTION SYSTEM, SERIAL NUMBER (B)(6), WAS PERFORMED ON (B)(6) 2024, WHICH CONFIRMED THAT THE INJECTOR WAS OPERATING WITHIN BAYER SPECIFICATIONS. THE DISPOSABLE KIT THAT WAS IN USE DURING THE PROCEDURE WAS DISCARDED BY THE SITE; HOWEVER, THE SITE PROVIDED A LOT NUMBER OF THE SUBJECT DISPOSABLE. BAYER PRODUCT ANALYSIS TESTED A RETAINED SAMPLE FROM DISPOSABLE FLEXD-150-SCS KIT, LOT NUMBER 8643936. FUNCTIONAL TESTING CONCLUDED THAT THE RETAINED DISPOSABLES PERFORMED TO SPECIFICATION WITH NO PROBLEMS OBSERVED. ADDITIONAL CLINICAL APPLICATIONS TRAINING WAS COMPLETED AND PROVIDED BY THE BAYER CLINICAL PERFORMANCE CENTER. THE MEDRAD® STELLANT FLEX CT INJECTION SYSTEM OPERATION MANUAL CAUTIONS THE USER AS FOLLOWS: WARNING: AIR EMBOLIZATION CAN CAUSE DEATH OR SERIOUS INJURY TO THE PATIENT. DO NOT CONNECT A PATIENT TO THE INJECTOR UNTIL ALL TRAPPED AIR HAS BEEN CLEARED FROM THE SYRINGE AND FLUID PATH. THIS INFORMATION DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE, THE COMPANY, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO A REPORTABLE EVENT.

    Additional Manufacturer Narrative · 0

    A SYSTEM SERVICE CHECK OF THE MEDRAD® STELLANT FLEX INJECTION SYSTEM, SERIAL NUMBER (B)(6), WAS PERFORMED ON (B)(6) 2024, WHICH CONFIRMED THAT THE INJECTOR WAS OPERATING WITHIN BAYER SPECIFICATIONS. THE DISPOSABLES THAT WERE IN USE DURING THE PROCEDURE WERE DISCARDED BY THE SITE; THEREFORE, THEY ARE NOT AVAILABLE FOR EVALUATION. THE CUSTOMER WAS UNABLE TO PROVIDE THE LOT NUMBER OF THE DISPOSABLES; THEREFORE, TESTING OF RETAINED SAMPLES WAS NOT POSSIBLE. THE OFFER OF ADDITIONAL CLINICAL APPLICATIONS TRAINING HAS BEEN ACCEPTED BY THE CUSTOMER AND WILL BE SCHEDULED. THE MEDRAD® STELLANT FLEX CT INJECTION SYSTEM OPERATION MANUAL CAUTIONS THE USER AS FOLLOWS: WARNING: AIR EMBOLIZATION CAN CAUSE DEATH OR SERIOUS INJURY TO THE PATIENT. DO NOT CONNECT A PATIENT TO THE INJECTOR UNTIL ALL TRAPPED AIR HAS BEEN CLEARED FROM THE SYRINGE AND FLUID PATH. 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 INFORMED THAT AN 87-YEAR-OLD FEMALE UNDERGOING A CT SCAN OF THE CHEST SUFFERED AN ALLEGED AIR INJECTION WHILE CONNECTED TO A MEDRAD® STELLANT FLEX CT INJECTION SYSTEM (SN (B)(6)). AFTER RECEIVING AN UNDISCLOSED AMOUNT OF AIR, THE PATIENT COMPLAINED OF SHORTNESS OF BREATH WITH DECREASING OXYGEN SATURATION. SUPPLEMENTAL OXYGEN WAS ADMINISTERED, AND THE PATIENT WAS TRANSFERRED TO THE EMERGENCY DEPARTMENT FOR FURTHER CARE. THE PATIENT WAS SUBSEQUENTLY DISCHARGED AND WAS REPORTED TO BE DOING WELL WITH NO FURTHER ISSUES REPORTED. NOTE: BAYER MEDICAL CARE INC. RECEIVED A MEDWATCH (MW5158297) FOR THIS ISSUE ON SEPTEMBER 3, 2024.

    Description of Event or Problem · 0

    BAYER MEDICAL CARE INC. WAS INFORMED THAT AN 87-YEAR-OLD FEMALE UNDERGOING A CT SCAN OF THE CHEST SUFFERED AN ALLEGED AIR INJECTION WHILE CONNECTED TO A MEDRAD® STELLANT FLEX INJECTION SYSTEM (SN (B)(6)). AFTER RECEIVING AN UNDISCLOSED AMOUNT OF AIR, THE PATIENT COMPLAINED OF SHORTNESS OF BREATH WITH DECREASING OXYGEN SATURATION. SUPPLEMENTAL OXYGEN WAS ADMINISTERED, AND THE PATIENT WAS TRANSFERRED TO THE EMERGENCY DEPARTMENT FOR FURTHER CARE. THE PATIENT WAS SUBSEQUENTLY DISCHARGED AND WAS REPORTED TO BE DOING WELL WITH NO FURTHER ISSUES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447068 STELLANT DUAL CT INJECTOR CT INJECTION SYSTEM DXT BAYER MEDICAL CARE INC 85577026 00616258011219

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Female Other FLEXD-150-SCS, LOT NUMBER 8643936