BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEMOCHRON JR.

    MDR report key: 28387 · Received November 6, 1995

    Report

    Report Number
    28387
    Event Type
    Injury
    Date Received
    November 6, 1995
    Date of Event
    August 24, 1995
    Report Date
    November 2, 1995
    Manufacturer
    INTERNATION TECHNIDYNE CORP.
    Product Code
    JBT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    PT UNDERGOING A STENT PROCEDURE IN THE CATHETERIZATION LABORATORY WAS GIVEN A BOLUS OF HEPARIN BEFORE BEING RELEASED TO CARDIAC INTENSIVE CARE UNIT FOR FOLLOW-UP. THE ACTIVATED CLOTTING TIME WAS 295 SECONDS BY THE INSTRUMENT USED IN CATH LAB. USING A NEW SYSTEM FOR ACT'S, THE HEMOCHRON DEVICE, THE SIMULTANEOUSLY PERFORMED ACT WAS 189. THE DISCREPANCY CAUSED PERSONNEL TO REPEAT THE ACTIVATED CLOTTING TIME USING BOTH DEVICES 30 MINUTES LATER. THE PT WAS FOLLOWED BY LABORATORY PERSONNEL USING BOTH SYSTEMS SIMULTANEOUSLY. THE RESULT WAS TO DELAY THE REMOVAL OF THE ARTERIAL LINES UNTIL AFTER 6PM, AN APPROPRIATE ACTION. HAD CATH LAB & CICU RELIED UPON THE RESULTS OF THE DEVICE, THE ARTERIAL LINES WOULD HAVE BEEN REQUESTED TO HAVE BEEN REMOVED AT LEAST 1 1/2 HRS EARLIER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEMOCHRON JR. MICROCOAGULATION INSTRUMENT JBT INTERNATION TECHNIDYNE CORP. ACV027, ACV024

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Life Threatening| R