BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEMOCHRON ELITE MICROCOAGULATION SYSTEM

    MDR report key: 1837293 · Received September 13, 2010

    Report

    Report Number
    2248721-2010-00127
    Event Type
    Death
    Date Received
    September 13, 2010
    Date of Event
    August 1, 2010
    Report Date
    September 13, 2010
    Manufacturer
    INTERNATIONAL TECHNIDYNE CORP.
    Product Code
    JPA
    PMA / PMN Number
    K050016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THROMBOELASTOGRAPH, FIBRINOGEN LEVEL, AND PLATELET COUNT CONSISTENT WITH "OUT OF RANGE LOW" RESULT FOR ACT TEST. CUSTOMER INDICATED INSTRUMENT DID NOT MALFUNCTION. ALL QUALITY CONTROL TESTS INDICATE PROPER PERFORMANCE. INSTRUMENT IS CURRENTLY BEING USED WITHOUT FURTHER INCIDENT. CUSTOMER INDICATED THAT RESULTS WERE APPROPRIATE FOR THE PATIENT'S CONDITION.

    Description of Event or Problem · 1

    CUSTOMER REPORTS PATIENT DEATH TWO DAYS AFTER AN AORTIC ANEURYSM BYPASS PROCEDURE WHERE HEMOCHRON ELITE INSTRUMENT ACT+ AND ACT-LR CUVETTE ASSAYS WERE USED. THE BASELINE ACT+ RESULT WAS OBTAINED AS THE PATIENT WAS IMMEDIATELY HEPARINIZED. ACT+ RESULTS IN THE 380-390 SECONDS RANGE WERE EXPECTED. PATIENT WAS PUT ON BYPASS AND ACT+ RESULTS OF "OUT OF RANGE LOW" WERE SUBSEQUENTLY OBTAINED. CUSTOMER THEN USED 3 ADDITIONAL HEMOCHRON ELITE INSTRUMENT AS WELL AS 6 DIFFERENT LOTS OF ACT+ AND ACT-LR CUVETTE ASSAYS AND CONTINUED OBTAINING RESULTS OF "OUT OF RANGE LOW". A THROMBOELASTOGRAPH, FIBRINOGEN, AND PLATELET TESTS INDICATED "VIRTUALLY NO PLATELET ACTIVITY" AS DESCRIBED BY THE CUSTOMER. AMICARB ADMINISTERED DURING BYPASS FOR PLATELETS. PATIENT WAS EVENTUALLY TAKEN OFF OF PUMP AND PROTAMINE ADMINISTERED PER HOSPITAL PROTOCOL AND ACT+ RESULT WAS "OUT OF RANGE LOW". PLATELETS WERE THEN ADMINISTERED AND EXPECTED ACT+ RESULTS WERE OBTAINED. TWO DAYS AFTER COMPLETION OF THE BYPASS THE PATIENT WAS DECEASED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Death