BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEMOCHRON SIGNATURE ELITE

    MDR report key: 2823767 · Received September 1, 2010

    Report

    Report Number
    2823767
    Event Type
    Injury
    Date Received
    September 1, 2010
    Date of Event
    June 8, 2010
    Report Date
    August 31, 2010
    Manufacturer
    INTERNATIONAL TECHNIDYNE CORP
    Product Code
    JBP
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT WENT TO SURGERY FOR PNEUMONECTOMY AND A BASELINE ACT WAS PERFORMED WITH A RESULT OF 117. PATIENT WAS GIVEN 20,000 UNITS OF HEPARIN AND THE ACT RESULT OF WAS 509. DURING SURGERY PT RECEIVED A TOTAL OF 18,000 MORE UNITS OF HEPARIN, AND 5 UNITS OF FRESH FROZEN PLASMA OVER THE NEXT HOUR WITH RESULTS RANGING FROM 394-455.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEMOCHRON SIGNATURE ELITE ACT METER JBP INTERNATIONAL TECHNIDYNE CORP C0JAC079

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention