BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEMOCHRON ELITE MICROCOAGULATION SYSTEM

    MDR report key: 1337121 · Received February 27, 2009

    Report

    Report Number
    2248721-2009-00001
    Event Type
    Injury
    Date Received
    February 27, 2009
    Date of Event
    December 3, 2008
    Report Date
    January 8, 2009
    Manufacturer
    INTERNATIONAL TECHNIDYNE CORP.
    Product Code
    JPA
    PMA / PMN Number
    K941007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ITC CLINICAL AFFAIRS REVIEWED CASE WITH RPTR. CUSTOMER REPORTS: DID NOT PERFORM PT BASELINE IN ACCORDANCE WITH PACKAGE INSERT. DID NOT PERFORM ESTIMATE OF HEPARIN LEVELS IN BLOOD BEFORE SHEATH PULL IN ACCORDANCE WITH PACKAGE INSERT. PULLED SHEATH 35 MINUTES AFTER ADMINISTERING 5000 UNITS HEPARIN IV. POST ADVERSE EVENT, RAN CONTROLS WITH ACCEPTABLE RESULTS. ITC CLINICAL AFFAIRS ADVISED WHEN USING ACT+ NEED TO PERFORM PT SPECIFIC BASELINE AS WELL AS TO ESTIMATE PT HEPARIN LEVELS IN ORDER TO INTERPRET RESULTS PROPERLY. CUSTOMER ADVISED IN LIGHT OF ABOVE, THEY DO NOT WANT TO RETURN PRODUCT FOR IN-HOUSE INVESTIGATION, AND INSTEAD WILL EVALUATE ACT-LR CUVETTE FOR USE IN SIMILAR CLINICAL APPLICATIONS. MANUFACTURER RESULTS, CONCLUSIONS - MANUFACTURER EVALUATION/INVESTIGATION CURRENTLY IN PROGRESS.

    Description of Event or Problem · 1

    CUSTOMER REPORTS INABILITY TO ACHIEVE PT HEMOSTASIS DURING CATH LAB PROCEDURE AT POINT OF SHEATH PULL WHILE USING HEMOCHRON ELITE/ACT+ CUVETTE. PROTAMINE ADMINISTERED TO ACHIEVE HEMOSTASIS, PT ADMITTED AND SUBSEQUENTLY GIVEN 2 UNITS OF BLOOD. PT DISCHARGED 4 DAYS LATER. NO FURTHER REPORTS OF ADVERSE EVENTS RELATED TO PT OR PRODUCT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEMOCHRON ELITE MICROCOAGULATION SYSTEM ELITE INSTRUMENT/ACT+ CUVETTE JPA INTERNATIONAL TECHNIDYNE CORP. ELITE H8JAC251

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R