BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACIST

    MDR report key: 780987 · Received November 13, 2006

    Report

    Report Number
    2134243-2006-00006
    Event Type
    Injury
    Date Received
    November 13, 2006
    Date of Event
    October 16, 2006
    Report Date
    November 13, 2006
    Manufacturer
    ACIST MEDICAL SYSTEMS, INC.
    Product Code
    DXT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER INVESTIGATION: H-3: SUMMARY OF EVALUATION OF RETURNED DEVICE: THE ACIST CMS2000 INJECTION SYSTEM WAS TAKEN OUT OF SERVICE AND RETURNED TO ACIST ON 10/19/2006. THE SYSTEM WAS TESTED AND PASSED ITS PRE-ESTABLISHED PERFORMANCE SPECIFICATIONS. DISPOSABLE KITS USED DURING THE EVENT WERE NOT RETAINED BY THE CUSTOMER; THEREFORE, NO ANALYSIS COULD BE PERFORMED ON THOSE ITEMS. CINEANGIOGRAM WAS RETURNED TO ACIST AND EVALUATED BY ACIST'S MEDICAL ADVISORY. AN AIR EMBOLUS WAS NOTED ON THE FIRST RUN. BECAUSE THE SYSTEM WAS DETERMINED TO BE OPERATING TO SPECIFICATIONS, THE ROOT CAUSE OF THE EVENT IS BELIEVED TO BE IMPROPER PURGING OF AIR IN THE LINE DURING SYSTEM SETUP.

    Description of Event or Problem · 1

    A USER FACILITY REPORTS: DURING A CORONARY ANGIOGRAM USING ACIST CM2000 ANGIOGRAPHIC INJECTOR, 5 CC OF AIR WAS INJECTED INTO PATIENT'S LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. PATIENT UNDERWENT EMERGENCY CORONARY ARTERY BYPASS SURGERY AND REMAINS HOSPITALIZED.

    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 74 YR Hospitalization