BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACT-LR CUVETTE ASSAY (HEMOCHRON SIGNATURE PLUS)

    MDR report key: 2543035 · Received April 16, 2012

    Report

    Report Number
    2248721-2012-00042
    Event Type
    Other
    Date Received
    April 16, 2012
    Date of Event
    March 1, 2012
    Report Date
    March 19, 2012
    Manufacturer
    INTERNATIONAL TECHNIDYNE CORP.
    Product Code
    JBP
    PMA / PMN Number
    K960749
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER TESTED USING INSTRUMENT SERIAL# (B)(4). METHOD: ACTUAL DEVICE NOT EVALUATED (SINGLE-USE DISPOSABLE). PROCESS EVAL PERFORMED. CUVETTE DEVICE HISTORY RECORDS REVIEWED AND FOUND TO MEET SPECS. RESULT: NO RESULTS AVAILABLE SINCE NO EVAL PERFORMED. CONCLUSIONS: UNABLE TO CONFIRM COMPLAINT. DEVICE NOT RETURNED. DEVELOPMENT OF BLOOD CLOTS WITHIN ECMO CIRCUITRY ARE ANTICIPATED OCCURRENCES THAT ARE MONITORED AND MANAGED WHEN OBSERVED. INSUFFICIENT INFO WAS PROVIDED TO DETERMINE IF A MALFUNCTION OCCURRED.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTS WHILE RUNNING ACT-LR ASSAY WITH HEMOCHRON SIGNATURE PLUS MICROCOAGULATION SYSTEM WITH PT ON EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO), CLOTS WERE OBSERVED IN THE ECMO CIRCUIT. SYSTEM PASSED ELECTRICAL QUALITY CONTROL AND LIQUID QUALITY CONTROL. NO ACT-LR RESULTS/DATA HAS BEEN PROVIDED. NO ADVERSE EVENT(S) REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACT-LR CUVETTE ASSAY (HEMOCHRON SIGNATURE PLUS) JBP INTERNATIONAL TECHNIDYNE CORP. M1JLR193-P1

    Patients

    Seq Age Sex Outcome Treatment
    1