BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOCHRON RESPONSE COAGULATION SYSTEM

    MDR report key: 1657237 · Received April 7, 2010

    Report

    Report Number
    2248721-2010-00067
    Event Type
    Malfunction
    Date Received
    April 7, 2010
    Report Date
    April 7, 2010
    Manufacturer
    INTERNATIONAL TECHNIDYNE CORP.
    Product Code
    KQG
    PMA / PMN Number
    K983475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MANUFACTURER AWAITING MEDICAL DEVICE RETURN FROM CUSTOMER FOR EVAL.

    Description of Event or Problem · 1

    HEALTH CARE PROFESSIONAL: REPORTS THE BLOOD CLOTTING TIME BETWEEN THE TWO TEST WELLS FOR HEMOCHRON RESPONSE HAD A DIFFERENCE OF OVER 60 SECONDS ALTHOUGH THE DOCTOR USED THE SAMPLE BLOOD SAMPLE PER CUSTOMER. POOR PT CORRELATION. PT WAS BEING MONITORED WHILE ON BYPASS, THE TARGETED RANGE FOR THE PT WAS -350 SEC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEMOCHRON RESPONSE COAGULATION SYSTEM HEMOCHRON RESPONSE COAGULATION ANALYZER KQG INTERNATIONAL TECHNIDYNE CORP. HRS.220

    Patients

    Seq Age Sex Outcome Treatment
    1