BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEMOCHRON SIGNATURE ELITE

    MDR report key: 2823764 · Received September 1, 2010

    Report

    Report Number
    2823764
    Event Type
    Injury
    Date Received
    September 1, 2010
    Date of Event
    June 18, 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

    PT WENT INTO SURGERY FOR CABG MVR WITH A BASELINE ACT OF 119, AFTER 40,000 UNITS OF HEPARIN WERE ADMINISTERED THE ACT RESULT RANGED FROM 397-426 AT 10:25 AM, AFTER AN ADD¿L 10,000 UNITS OF HEPARIN WERE GIVEN TO THE PT THE ACT RESULT WAS 377 AT 10:30, AND FINALLY AT 11:00 AM ACT RESULTS RANGED BETWEEN 367-437 SECONDS.

    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 49 YR Required Intervention