BEUDAMED
    FDA Adverse Event Other Summary report: N

    HEMOCHRON 801 MICROCOAGULATION SYSTEM

    MDR report key: 1943669 · Received December 15, 2010

    Report

    Report Number
    2248721-2010-00180
    Event Type
    Other
    Date Received
    December 15, 2010
    Report Date
    November 16, 2010
    Manufacturer
    INTERNATIONAL TECHNIDYNE CORP
    Product Code
    JPA
    PMA / PMN Number
    TBD
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR SUBMITTED (B)(4) 2010, (B)(4). METHOD, RESULTS AND CONCLUSIONS: MANUFACTURER/EVALUATION/INVESTIGATION CURRENTLY IN PROCESS. ITC HAS REQUESTED ALL DATA REQUIRED FOR FORM 3500A.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED UNEXPECTED CLOTTING WITHIN THE EXTRACORPOREAL MEMBRANE OXYGENATOR (ECMO) SYSTEM DURING INTENSIVE CARE UNIT PROCEDURE FOLLOWING HEPARIN ADMINISTRATION TO A PT BEING TREATED FOR "ORGANIC PHOSPHATE" INTOXICATION. BOTH THE INSTRUMENT AND TEST TUBES WERE ASSESSED AND THE LIQUID QUALITY CONTROL OF THE SYSTEM PASSED. AFTER THE PROCEDURE, REPEAT ACTIVATED CLOTTING TIME TESTING USED A DIFFERENT TYPE TEST ((B)(4)) RESULTS FIT THE ANTICOAGULANT THERAPY. ACT RESULTS: (DATES/TIMES NOT REPORTED) - 200 SECONDS THE FIRST 8 DAYS, BLOOD CLOTS NOTED DURING ECMO PROCEDURE, 130 SECONDS 130 SECONDS WITH (B)(4), 130 SECONDS WITH HEPCON MACHINE. HEMODYNAMIC IMBALANCE WAS REPORTED AS UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEMOCHRON 801 MICROCOAGULATION SYSTEM HEMOCHRON INSTRUMENT 801 JPA INTERNATIONAL TECHNIDYNE CORP HE801.220V 9PGE1238

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Hospitalization| O