BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEMOCHRON SIGNATURE ELITE

    MDR report key: 2823757 · Received September 1, 2010

    Report

    Report Number
    2823757
    Event Type
    Injury
    Date Received
    September 1, 2010
    Date of Event
    June 22, 2010
    Report Date
    August 31, 2010
    Manufacturer
    INTERNATIONAL TECHNIDYNE CORP
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS IN CARDIAC OPERATING ROOM UNDERGOING A CABG PROCEDURE WHEN THE ACT RESULTS FROM A HEMOCHRON SIGNATURE ELITE FROM INTERNATIONAL TECHNIDYNE CORP WASN¿T YIELDING THE TYPE OF RESULTS TYPICALLY SEEN WITH THE DOSAGE OF HEPARIN THE PT WAS GIVEN. THE ACT READING WAS TOO LOW AFTER MULTIPLE DOSES OF HEPARIN. AFTER WAITING SOME TIME FOR THE ACT TO ELEVATE, THE PT¿S ACT RESULT WOULD ONLY READ UP TO 544.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention