BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEMOCHRON MICROCOAGULATION SYSTEM

    MDR report key: 1313086 · Received February 10, 2009

    Report

    Report Number
    2248721-2009-00044
    Event Type
    Death
    Date Received
    February 10, 2009
    Date of Event
    September 24, 2008
    Report Date
    February 10, 2009
    Manufacturer
    INTERNATIONAL TECHNIDYNE CORPORATION
    Product Code
    JBP
    PMA / PMN Number
    K960749
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MDR FILING DUE TO RECENT RECEIPT OF INFORMATION BY ITC CLARIFYING REPORTING RULES WHERE BOTH MULTIPLE PATIENTS AND MULTIPLE DEVICES ARE INVOLVED. DUE TO THIS, MDR'S 2248721-2008-00018 AND 2248721-2008-00019 HAVE BEEN PREVIOUSLY FILED RELATED TO SAME REPORTED ADVERSE EVENTS. CUSTOMER REPORTS HEMOCHRON SIGNATURE ELITE, BUT IS UNABLE TO SPECIFICALLY IDENTIFY WHICH INSTRUMENT(S) ARE INVOLVED IN EACH SPECIFIC ADVERSE EVENT. IN 2008, INTERNATIONAL TECHNIDYNE CORPORATION PERFORMED AN ON SITE INVESTIGATION OF THE DEVICE ALLEGED TO BE INVOLVED. THE FOLLOWING EVALUATIONS WERE PERFORMED: PHYSICAL DAMAGE, HEPARIN RESPONSE, PRECISION, DATA DOWNLOAD FROM DEVICE MEMORY. THE RESULTS OF THE ABOVE EVALUATIONS CONCLUDED THAT THE DEVICE IS, AND WAS OPERATING IN ACCORDANCE WITH MANUFACTURING SPECIFICATIONS, AND THAT THE FACILITY CONTINUES TO USE THE DEVICE WITHOUT FURTHER REPORTS OF MALFUNCTIONS.

    Description of Event or Problem · 1

    CUSTOMER REPORTS 4 CRITICALLY ILL PEDIATRIC ECMO PATIENTS EXPIRED OVER AN UNSPECIFIED SIX WEEK PERIOD. DURING TREATMENT, CLOTTING TIME WAS MEASURED USING HEMOCHRON ACT-LR / SIGNATURE ELITE INSTRUMENTS. AS 2 SIGNATURE ELITE INSTRUMENTS ARE IN USE, CUSTOMER IS UNABLE TO IDENTIFY WHICH INSTRUMENT USED WITH SPECIFIC PATIENTS. CUSTOMER REVIEWING MEDICATION REGIMEN FOR CASUALITY. THIS REPORT IS FOR PATIENT 4 OF 4.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEMOCHRON MICROCOAGULATION SYSTEM ACT-LR ASSAY / SIGNATURE ELITE INSTRUMEMENT JBP INTERNATIONAL TECHNIDYNE CORPORATION SIGNATURE ELITE ACT-LR-UNAVAILABLE

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR Death