BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEMOCHRON ELITE MICROCOAGULATION SYSTEM

    MDR report key: 1295443 · Received January 22, 2009

    Report

    Report Number
    2248721-2009-00009
    Event Type
    Death
    Date Received
    January 22, 2009
    Date of Event
    December 30, 2008
    Report Date
    January 22, 2009
    Manufacturer
    INTERNATIONAL TECHNIDYNE CORP.
    Product Code
    JBP
    PMA / PMN Number
    K941007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT SAMPLES HAVE BEEN RETURNED AND ARE PENDING EVALUATION/INVESTIGATION. ADDITIONALLY, ITC CLINICAL AFFAIRS CONTACTED THE POC COORDINATOR WHO RELATED THE FOLLOWING: DURING THE FIRST WEEK IN EARLY 2009, THE PHYSICIAN NOTED HIS EXPECTATIONS REGARDING RESULTS IN RELATION TO HEPARIN DOSE RESPONSE WERE BASED ON PREVIOUS EXPERIENCE AT ANOTHER FACILITY USING A NON-ITC POC INSTRUMENT WHICH EMPLOYS A DIFFERENT METHODOLOGY OF CLOT DETECTION. THE PHYSICIAN WAS NOT USING THE "NORMAL" BASELINE ESTABLISHED FOR THE HEMOCHRON SIGNATURE ELITE AND ACT+ SYSTEM BY THE MEDICAL CENTER. THE PHYSICIAN EXPECTATION FOR TARGET RANGES FOR INTERVENTIONAL RADIOLOGY PROCEDURES WERE NOT DEVELOPED SPECIFICALLY FOR THE HEMOCHRON SIGNATURE ELITE AND ACT+ SYSTEM AS PER PACKAGE INSERT DIRECTIONS, BUT INSTEAD CARRIED OVER FROM ANOTHER FACILITY THAT USED A DIFFERENT POC SYSTEM AND CLOT DETECTION METHODOLOGY. THE POC COORDINATOR EDUCATED THE PHYSICIAN THAT EACH MANUFACTURER OF POC COAGULATION DEVICES HAS UNIQUE/PROPRIETARY METHODS FOR CLOT DETERMINATION, AND DEVICE-TO-DEVICE PERFORMANCE AND RESULT EXPECTATIONS VARY. MANUFACTURER METHOD CODE - MANUFACTURER EVALUATION/ INVESTIGATION CURRENTLY IN PROCESS.

    Description of Event or Problem · 1

    POC COORDINATOR REPORTS 2 PATIENT ADVERSE EVENTS AND 1 PATIENT RELATED MALFUNCTION ASSOCIATED WITH THE PHYSICIAN REPORTED LOWER THAN EXPECTED RESULTS WITH THE HEMOCHRON ELITE INSTRUMENT / ACT+ ASSAY. THIS REPORT IS FOR THE PATIENT 2 OF 3 WHERE PATIENT EXPIRED. PRIOR TO ANY HEMOCHRON PRODUCT USE, PATIENT SUFFERED A CEREBRAL ANEURYSM RUPTURE WHICH REQUIRED HOSPITALIZATION. UPON ARRIVAL AT HOSP, PATIENT SUFFERED A RUPTURE OF A SECOND CEREBRAL ANEURYSM. A VENTRICULOSTOMY WAS PERFORMED BY THE INTERVENTIONAL RADIOLOGY DEPT REQUIRING THE ADMINISTRATION OF HEPARIN AND UTILIZATION OF ELITE INSTRUMENT / ACT+ ASSAY. PHYSICIAN TREATING PATIENT BELIEVED ACT+ RESULTS WERE LOWER THAN EXPECTED. PATIENT SUBSEQUENTLY TRANSFERRED TO ICU AFTER PROCEDURE AND EXPIRED 5 DAYS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEMOCHRON ELITE MICROCOAGULATION SYSTEM ELITE INSTRUMENT / ACT+ ASSAY JBP INTERNATIONAL TECHNIDYNE CORP. ELITE J8JAC296

    Patients

    Seq Age Sex Outcome Treatment
    1 Death