BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STELLANT DUAL CT INJECTOR

    MDR report key: 19720151 · Received July 11, 2024

    Report

    Report Number
    2520313-2024-00014
    Event Type
    Injury
    Date Received
    July 11, 2024
    Date of Event
    April 21, 2024
    Report Date
    July 11, 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
    CO, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    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 USED DURING THE PROCEDURE; THEREFORE, TESTING OF RETAINED SAMPLES WAS NOT POSSIBLE. THE OFFER OF ADDITIONAL CLINICAL APPLICATIONS TRAINING HAS BEEN ACCEPTED BY THE CUSTOMER AND WAS PROVIDED BY THE 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.

    Description of Event or Problem · 0

    BAYER MEDICAL CARE INC. WAS INFORMED THAT A 74-YEAR-OLD MALE INPATIENT UNDERGOING A CT SCAN FOR A PULMONARY EMBOLISM SUFFERED AN ALLEGED AIR INJECTION WHILE CONNECTED TO A MEDRAD® STELLANT FLEX INJECTION SYSTEM (SN (B)(6)). IT WAS REPORTED THAT AN ESTIMATED 5 ML OF AIR WAS NOTICED ON THE DISPLAYED IMAGES. FOLLOWING THE EVENT, THE PATIENT WAS REPORTED TO HAVE BEEN INTUBATED AND, AFTER AN UNDISCLOSED PERIOD OF TIME, THE PATIENT WAS DISCHARGED TO HOME WITH NO FURTHER ISSUES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2385965 STELLANT DUAL CT INJECTOR CT INJECTION SYSTEM DXT BAYER MEDICAL CARE INC 85577026 00616258011219

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male Other