BEUDAMED
    FDA Adverse Event Death Summary report: N

    MEDRAD CT INJECTOR SYSTEM &QUIK FIT SYRINGE

    MDR report key: 3970726 · Received July 8, 2014

    Report

    Report Number
    2520313-2014-00037
    Event Type
    Death
    Date Received
    July 8, 2014
    Date of Event
    May 13, 2014
    Report Date
    June 19, 2014
    Manufacturer
    BAYER MEDICAL CARE, INC.
    Product Code
    DXT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A SYSTEM SERVICE CHECK OF THE ENVISION CT INJECTOR SYSTEM SERIAL NUMBER (B)(4) WAS COMPLETED ON MAY 15, 2014 WHICH CONFIRMED THAT THE INJECTOR WAS OPERATING WITHIN BAYER R & I SPECS. THE CUSTOMER DID NOT RETAIN THE DISPOSABLES THAT WERE IN USE DURING THE REPORTED EVENT; THEREFORE, THEY ARE NOT AVAILABLE FOR EVAL. THE CUSTOMER WAS UNABLE TO PROVIDE THE LOT NUMBERS OF THE DISPOSABLES THAT WERE IN USE; THEREFORE, WE ARE UNABLE TO TEST ANY RETAINED SAMPLES. THE SITE CONTINUES TO USE THE ENVISION CT INJECTOR SYSTEM AND GE LIGHTSPEED PLUS (H2) SCANNER AFTER THE REPORTED EVENT - NO FURTHER ISSUES WERE REPORTED. IN THE EVENT ADD'L INFO IS OBTAINED, A F/U REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ON (B)(6) 2014, BAYER R & I RECEIVED INFO FROM GE HEALTHCARE REGARDING AN ADVERSE EVENT THAT OCCURRED DURING A CT SCAN WHILE A BAYER MEDRAD ENVISION CT INJECTOR SYSTEM AND A GE LIGHTSPEED PLUS (H2) SCANNER WERE IN USE. A (B)(6) MALE PT, WITH PAST MEDICAL HISTORY OF CARDIAC PROBLEMS, EXPERIENCED A SYNCOPAL EPISODE WHILE IN THE HOSPITAL'S PARKING LOT. THE PT WAS TAKEN TO THE EMERGENCY DEPARTMENT AND WAS SENT TO THE CT DEPARTMENT TO UNDERGO A CT SCAN OF THE CHEST AND ABDOMEN TO RULE OUT AN AORTIC DISSECTION. THE CT SCAN OF THE HEAD WAS COMPLETED WITHOUT ANY ISSUE. DURING THE NON-CONTRAST PHASE OF THE CHEST AND ABDOMEN, THERE WAS A LOUD NOISE WHICH INTERRUPTED THE SCAN. THE ETIOLOGY OF THE NOISE (I.E. SCANNER AND/OR INJECTOR/DISPOSABLES) WAS NOT ABLE TO BE DETERMINED. THE NON-CONTRAST SCAN OF THE ABDOMEN AND PELVIS WAS RESTARTED AND COMPLETED WITHOUT ANY ISSUE. SHORTLY AFTER THE CONTRAST PHASE OF THE EXAM HAD BEGUN, IT WAS NOTED THAT THE IMAGES DID NOT HAVE ANY ENHANCEMENT AND THE SCAN WAS STOPPED. THE PT WAS EVALUATED AND FOUND TO HAVE SUFFERED A CARDIAC EVENT. CPR WAS ADMINISTERED BY THE STAFF BUT THE PT COULD NOT BE RESUSCITATED AND; THEREFORE, CEASED TO BREATHE. AN AUTOPSY WAS DECLINED BY THE PT'S FAMILY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    395622 MEDRAD CT INJECTOR SYSTEM &QUIK FIT SYRINGE CT INJECTOR AND QWIK FIT SYRINGE DXT BAYER MEDICAL CARE, INC. ECT 700

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Death