BEUDAMED
    FDA Adverse Event Death Summary report: N

    MEDRAD MR INJECTOR

    MDR report key: 2987698 · Received February 27, 2013

    Report

    Report Number
    2520313-2013-00010
    Event Type
    Death
    Date Received
    February 27, 2013
    Date of Event
    January 29, 2013
    Report Date
    January 29, 2013
    Manufacturer
    MEDRAD
    Product Code
    DXT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MR SPECTRIS SOLARIS INJECTOR (SERIAL NUMBER (B)(4)) HAS BEEN QUARANTINED SINCE (B)(4) 2013. (B)(6) HEALTH AUTHORITIES WILL NOT PERMIT BAYER R AND I TO EVALUATE THE EQUIPMENT AT THIS TIME. THE TECHNICAL SERVICE REPORT DATED JUN 12, 2012 INDICATED THAT THE MR INJECTOR WAS PERFORMING TO SPECIFICATIONS. IN THE EVENT ADDITIONAL INFO IS OBTAINED, A F/U REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A BAYER PHARMACOVIGILANCE REP REPORTED THE FOLLOWING: THREE ALLEGED FATALITIES OCCURRED FOLLOWING THE ADMINISTRATION OF AN MR CONTRAST AGENT. THESE FATALITIES WERE THE LAST THREE EXAMS OF THE DAY. PLEASE REF BAYER PHARMA (B)(4) REPORT(S) NUMBER 2013-012510 AND 2013-012496 FOR FURTHER INFO. THE MEDRAD SPECTRIS SOLARIS INJECTOR (SERIAL NUMBER (B)(4)) WAS IN USE WHILE TWO OF THE PTS WERE GIVEN MR CONTRAST MEDIA. THE (B)(6) HEALTH AUTHORITIES ARE CURRENTLY CONDUCTING AN INVESTIGATION AND THEREFORE LIMITED INFO HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84495 MEDRAD MR INJECTOR MR INJECTOR DXT MEDRAD SPECTRIS MR INJECTOR

    Patients

    Seq Age Sex Outcome Treatment
    1 Death