BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDRAD ANGIOGRAPHIC/CT INJECTOR

    MDR report key: 18303171 · Received December 11, 2023

    Report

    Report Number
    2520313-2023-00034
    Event Type
    Injury
    Date Received
    December 11, 2023
    Date of Event
    November 14, 2023
    Report Date
    September 23, 2024
    Manufacturer
    BAYER MEDICAL CARE INC.
    Product Code
    DXT
    UDI-DI
    00616258021362
    PMA / PMN Number
    K113133
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A SYSTEM SERVICE CHECK OF THE MEDRAD® MARK 7 ARTERION INJECTION SYSTEM (SERIAL NUMBER (B)(6) WAS COMPLETED ON NOVEMBER 15, 2023 WHICH CONFIRMED THAT THE INJECTOR WAS OPERATING WITHIN BAYER SPECIFICATIONS. MULTIPLE DOCUMENTED ATTEMPTS HAVE BEEN MADE TO GAIN SPECIFIC INFORMATION RELATED TO THE REPORTED EVENT, INCLUDING THE DISPOSABLES INVOLVED; HOWEVER, THESE ATTEMPTS HAVE BEEN UNSUCCESSFUL. IN THE EVENT THAT ADDITIONAL INFORMATION IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED. 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

    UDI RELATED DATA QUALITY UPDATES ONLY. CORRECTION: FOR UDI DATA DISCREPANCY/MISMATCH ON PREVIOUSLY SUBMITTED MDR AND TO ENSURE THE DEVICE IDENTIFICATION DATA IS IN ALIGNMENT WITH GUDID.

    Description of Event or Problem · 0

    ON NOVEMBER 15, 2023, BAYER MEDICAL CARE INC. RECEIVED INFORMATION THAT A PATIENT SUFFERED A CARDIAC ARREST WHILE CONNECTED TO A MEDRAD® MARK 7 ARTERION INJECTION SYSTEM (SERIAL NUMBER (B)(6). THE CUSTOMER REPORTED THAT THE INJECTOR FAILED TO RESPOND AFTER BEING ARMED. AS THE STAFF WERE ATTEMPTING TO TROUBLESHOOT THE INJECTOR ISSUE, THE PATIENT'S BLOOD PRESSURE DROPPED WHICH PROGRESSED TO CARDIAC ARREST. THE CUSTOMER REPORTED THAT, AFTER SUCCESSFUL RESUSCITATION, THE INJECTOR WAS RETURNED TO NORMAL OPERATION AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE CUSTOMER ALSO REPORTED THAT THE PATIENT HAS RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1081572 MEDRAD ANGIOGRAPHIC/CT INJECTOR ANGIOGRAPHIC/CT INJECTOR DXT BAYER MEDICAL CARE INC. 86410095 00616258021362

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other