BEUDAMED
    FDA Adverse Event Death Summary report: N

    ACIST

    MDR report key: 771322 · Received October 17, 2006

    Report

    Report Number
    2134243-2006-00005
    Event Type
    Death
    Date Received
    October 17, 2006
    Date of Event
    October 5, 2006
    Report Date
    October 17, 2006
    Manufacturer
    ACIST MEDICAL SYSTEMS, INC.
    Product Code
    DXT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER INVESTIGATION: THE INJECTION SYSTEM WAS TAKEN OUT OF SERVICE ON 6 OCTOBER 2006 AND RETURNED TO ACIST MEDICAL SYSTEMS. THE DEVICE PASSED FUNCTIONAL TESTING. CINE FILM WAS NOT AVAILABLE AS THE HOSPITAL WOULD NOT RELEASE THIS INFORMATION. MANUFACTURING PROPOSED NEXT ACTIONS: FURTHER INVESTIGATION.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTS: THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH CARDIOGENIC SHOCK. AN ANGIOGRAPHIC PROCEDURE WAS STARTED ON THE PATIENT. AFTER THE FIRST INJECTION OF CONTRAST MEDIA, THE PHYSICIAN THOUGHT HE MAY HAVE SEEN AIR BUBBLES WITH THE CONTRAST MEDIA, BUT WAS UNCERTAIN. NO IMMEDIATE CHANGE WAS UNCERTAIN. NO IMMEDIATE CHANGE WAS NOTED IN THE PATIENT'S CONDITION, HOWEVER, THE PATIENT SUBSEQUENTLY DIED. REPORTER'S COMMENT: THE PHYSICIAN DOES NOT THINK THE DEATH WAS RELATED TO THE SYSTEM OR INJECTION OF SMALL AIR BUBBLES. ADDITIONAL INFORMATION IS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACIST ANGIOGRAPHIC INJECTION SYSTEM DXT ACIST MEDICAL SYSTEMS, INC. CMS2000 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death