BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEMOCHRON ELITE MICROCOAGULATION SYSTEM

    MDR report key: 1883987 · Received October 20, 2010

    Report

    Report Number
    2248721-2010-00150
    Event Type
    Death
    Date Received
    October 20, 2010
    Date of Event
    October 1, 2010
    Report Date
    October 7, 2010
    Manufacturer
    INTERNATIONAL TECHNIDYNE CORPORATION
    Product Code
    JPA
    PMA / PMN Number
    K050016
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PT DEATH WAS NOT DUE TO THE INSTRUMENT IN THIS REPORT. THERE ARE TWO STAGES TO DIC. IN THE EARLY STAGE, THERE IS WIDESPREAD ACTIVATION OF CLOTTING FACTORS. AT THIS STAGE, ACT IS EXPECTED TO BE VERY SHORT. AS DIC PROGRESSES, CLOTTING FACTORS ARE CONSUMED AND ANTI-CLOTTING FACTORS BECOME ACTIVATED. AT THIS STAGE, ACT IS TYPICALLY MARKEDLY PROLONGED. THE ACT'S OBSERVED IN THIS COMPLAINT ARE CONSISTENT WITH THE TWO PHASES OF DIC, AND THEREFORE, THE CHAIRMAN OF ITC'S MEDICAL ADVISORY BOARD BELIEVES THE ACT INSTRUMENT PERFORMED AS EXPECTED. IN ADDITION, THE CUSTOMER NOTIFIED ITC THAT PRIOR TO AND POST EVENT QUALITY CONTROL TESTS WERE PERFORMED. THE TEST RESULTS DEMONSTRATED PROPER SYSTEM PERFORMANCE. MANUFACTURER AWAITING ADDITIONAL INFO FOR FURTHER COMPLAINT EVAL.

    Description of Event or Problem · 1

    CUSTOMER REPORTED OUTSIDE REPORTABLE RANGE LOW ACT RESULTS WITH THE SIGNATURE ELITE INSTRUMENT AND A PT DEATH THAT WAS NOT RELATED TO THE INSTRUMENT. A PT IN CARDIOVASCULAR OPERATING ROOM BEGAN GENERATING < 65 ACT+ RESULTS ON MULTIPLE INSTRUMENTS WITH MULTIPLE CUVETTE LOTS. DURING THE OPERATION, ACT+ RESULT WAS 639, 30 MINUTES LATER ADDITIONAL HEPARIN WAS GIVEN AND ACT RESULT WAS 1000. THE INSTRUMENT THEN GENERATED OUT-OF-RANGE LOW RESULTS. THE TEST WAS REPEATED ON MULTIPLE INSTRUMENTS, AND MULTIPLE CUVETTE LOTS WITH OUT-OF-RANGE LOW RESULTS GENERATED. CUSTOMER LATER SENT AN E-MAIL INDICATING THE PT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEMOCHRON ELITE MICROCOAGULATION SYSTEM SIGNATURE ELITE INSTRUMENT JPA INTERNATIONAL TECHNIDYNE CORPORATION ELITE

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Death