BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOCHRON ELITE MICROCOAGULATION SYSTEM

    MDR report key: 2844345 · Received November 8, 2012

    Report

    Report Number
    2248721-2012-00129
    Event Type
    Malfunction
    Date Received
    November 8, 2012
    Date of Event
    October 5, 2012
    Report Date
    October 10, 2012
    Manufacturer
    INTERNATIONAL TECHNIDYNE CORP.
    Product Code
    JPA
    PMA / PMN Number
    K050016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CUVETTE LOT # F2JLR104. METHOD: ACTUAL DEVICE EVALUATED (INSTRUMENT). PROCESS EVALUATION PERFORMED. CUVETTE DEVICE HISTORY RECORDS REVIEWED AND FOUND TO MEET SPECIFICATIONS. RESULT: COMPLAINT WAS NOT CONFIRMED THROUGH THE INSTRUMENT EVALUATION. CONCLUSION CODE: UNABLE TO CONFIRM COMPLAINT. ITC HAS REQUESTED ALL DATA REQUIRED FOR FORM 3500A.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTS LOWER THAN EXPECTED ACT-LR RESULTS WITH THE HEMOCHRON SIGNATURE ELITE MICROCOAGULATION SYSTEM DURING A CARDIAC ABLATION PROCEDURE IN THE ELECTROPHYSIOLOGY LAB. THE INITIAL BASELINE ACT-LR RESULT WAS 134 SECONDS. AFTER FIRST BOLUS OF HEPARIN WAS ADMINISTERED, ACT-LR RESULT WAS 285 SECONDS. SINCE THE RESULT DID NOT REACH THE THERAPEUTIC TARGET TIME OF >300 SECONDS, AN ADDITIONAL BOLUS OF HEPARIN WAS ADMINISTERED. THE FOLLOWING ACT-LR TEST GENERATED RESULT OF 235 SECONDS AND DID NOT INCREASE ASS EXPECTED. A COMPARISON TEST WAS PERFORMED DURING A SECOND ELITE INSTRUMENT. ACT-LR RESULT WAS 253 SECONDS ON THE FIRST INSTRUMENT AND 347 SECONDS ON THE SECOND INSTRUMENT. THE PROCEDURE WAS CONTINUED USING THE SECOND INSTRUMENT AND ALL SUBSEQUENT RESULTS WERE AS EXPECTED. TARGET TIME: >300 SECONDS. NO ADVERSE EVENTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEMOCHRON ELITE MICROCOAGULATION SYSTEM JPA INTERNATIONAL TECHNIDYNE CORP. ELITE

    Patients

    Seq Age Sex Outcome Treatment
    1