BEUDAMED
    FDA Adverse Event Death Summary report: N

    CT TRI-PAK

    MDR report key: 1244068 · Received November 25, 2008

    Report

    Report Number
    2520313-2008-00021
    Event Type
    Death
    Date Received
    November 25, 2008
    Date of Event
    November 9, 2007
    Report Date
    November 26, 2008
    Manufacturer
    MEDRAD, INC.
    Product Code
    DXT
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MEDRAD HAS MADE MULTIPLE ATTEMPTS TO GATHER INFORMATION TO ASSIST WITH OUT INVESTIGATION. AT THIS TIME, WE HAVE NOT RECEIVED THE REQUESTED INFORMATION. IF WE RECEIVE THE REQUESTED INFORMATION AND ARE ABLE TO COMPLETE A PROPER INVESTIGATION INTO THIS INCIDENT, A FOLLOW-UP REPORT WILL BE SUBMITTED. IN ADDITION, A REVIEW OF OUR SERVICE RECORDS FOUND THAT FROM 2007, TO THE PRESENT, MEDRAD HAS NOT BEEN INFORMED BY THE HOSPITAL OF ANY MECHANICAL OR OPERATIONAL ISSUES WITH THE INJECTOR THAT WAS ALLEGEDLY INVOLVED IN THIS INCIDENT; NOR HAS MEDRAD BEEN ASKED TO PERFORM ANY SERVICE OR WARRANTY WORK ON THIS EQUIPMENT OUTSIDE OF ROUTINE MAINTENANCE. A SEARCH OF THE COMPLAINT DATABASE FOUND THAT THERE ARE NO COMPLAINTS, SIMILAR OR OTHERWISE, FOR ANY OF THE BATCHES OF THIS PRODUCT THAT WERE SOLD TO THIS CUSTOMER.

    Description of Event or Problem · 1

    A MEDRAD SALES REPRESENTATIVE WAS INFORMED ON OCTOBER 31, 2008, OF AN ALLEGED AIR INJECTION THAT LED TO A PATIENT DEATH IN 2007. THE PATIENT WAS SCHEDULED FOR A PULMONARY EMBOLI CT SCAN . THE STUDY WAS REPORTEDLY COMPLETED WITHOUT INCIDENT. THE PATIENT CODED DURING TRANSPORT TO ANOTHER PART OF THE HOSPITAL AND THEN PASSED AWAY. WE WERE TOLD THAT THE FIRST AUTOPSY CONTAINS NO REFERENCE TO AIR AS A POTENTIAL CAUSE OF DEATH, BUT THAT THE SECOND AUTOPSY ALLEGEDLY CONTAINS A CONCLUSION THAT THE CAUSE OF DEATH WAS AIR. IT WAS REPORTED THAT AN INVESTIGATION WAS RECENTLY CONDUCTED AT THE HOSPITAL DURING WHICH A TECHNOLOGIST REPORTED THAT THEY REMEMBER TAKING THE SYRINGE OFF OF THE INJECTOR AND NOTICING THAT THE PLUNGER WAS DISLODGED AND SITTING SIDEWAYS IN THE SYRINGE, ALLEGEDLY ALLOWING AIR INTO THE SYRINGE. THE HOSPITAL IS QUESTIONING IF THE AIR WAS INDUCED TO THE PATIENT BY THE SYRINGE. WE HAVE REQUESTED ADDITIONAL INFORMATION INCLUDING: THE SERIAL NUMBER OF THE INJECTOR THAT WAS IN USE, THE LOT NUMBER OF THE SYRINGE KIT, PATIENT INFORMATION, ETC., BUT HAVE NOT RECEIVED A RESPONSE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CT TRI-PAK CT SRYINGES DXT MEDRAD, INC. CTP 100 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death