BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEMOCHRON ELITE MICROCOAGULATION SYSTEM

    MDR report key: 1695197 · Received May 19, 2010

    Report

    Report Number
    2248721-2010-00082
    Event Type
    Death
    Date Received
    May 19, 2010
    Report Date
    April 19, 2010
    Manufacturer
    INTERNATIONAL TECHNIDYNE CORP.
    Product Code
    JPA
    PMA / PMN Number
    K050016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). THE INFO DOES NOT INDICATE A DEVICE MALFUNCTION OR THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE PURPORTED DEATH. THE DEVISE USER WAS SURPRISED THAT EXPECTED PROLONGATION OF ACT TIME DID NOT OCCUR AFTER THE PT RECEIVED 40,000 UNITS OF HEPARIN WHILE UNDERGOING CPR. THE USER ATTRIBUTED THIS TO THE NEW HEPARIN STANDARDIZATION, AND CALLED ITC FOR ASSISTANCE. ITC COUNSELLED USER THAT IT WAS HIGHLY UNLIKELY FOR HEPARIN TO EQUIBRATE WHILE PT IS RECEIVING CPR. NO PRODUCT RETURNED FROM MEDICAL FACILITY. MANUFACTURER'S RESULTS - MANUFACTURER'S EVAL OF DEVICE HISTORY RECORD DID NOT INDICATE A PROBLEM WITH THE DEVICE. MANUFACTURER'S CONCLUSION - NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    THIS MDR IS FILED DUE TO TEMPORAL PROXIMITY BETWEEN USE OF THE DEVICE AND A PT DEATH. CUSTOMER CALLED FOR ASSISTANCE IN UNDERSTANDING ACT RESULTS WHICH DID NOT MATCH THE CLINICIAN'S EXPECTATION AFTER THE ADMINISTRATION OF 40,000 UNITS OF HEPARIN. THE PT WENT INTO CARDIAC ARREST AND EXPIRED APPROXIMATELY 1 HOUR AFTER AN INTERVENTIONAL CARDIAC CATHETERIZATION THAT COMPLETED WITHOUT INCIDENT. THERE IS NO EVIDENCE OR ALLEGATION OF HEMOCHRON SIGNATURE ELITE DEVICE MALFUNCTION. THIS MDR IS FILED DUE TO TEMPORAL PROXIMITY BETWEEN USE OF THE DEVICE AND THE DEATH.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Death