BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEMOCHRON JR SIGNATURE PLUS SYSTEM

    MDR report key: 3940281 · Received June 19, 2014

    Report

    Report Number
    2248721-2014-00025
    Event Type
    Injury
    Date Received
    June 19, 2014
    Date of Event
    May 20, 2014
    Report Date
    May 20, 2014
    Manufacturer
    INTERNATIONAL TECHNIDYNE CORP
    Product Code
    JPA
    PMA / PMN Number
    K020798
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: ACTUAL DEVICE WAS NOT EVALUATED. PROCESS EVALUATION WAS PERFORMED. NO RELATED NCRS WERE IDENTIFIED FOR THIS INSTRUMENT. CUVETTE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO MEET SPECIFICATION. CONCLUSION CODE: THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. THE CUSTOMER WAS ADVISED THAT THE CITRATE PT TEST IS VALUABLE DURING PROCEDURES AND THERAPEUTIC INTERVENTIONS THAT REQUIRE MONITORING OF ORAL ANTICOAGULANTS AND FOR HEMOSTASIS ASSESSMENT, BUT IS NOT INTENDED FOR ANTICOAGULANTS THAT AFFECTED THE INTRINSIC COAGULATION PATHWAY, I.E. HEPARIN. THE INSTRUMENTS WERE NOT TAKEN OUT OF USE AND ARE GENERATING ACCURATE RESULTS WITH OTHER PTS.

    Description of Event or Problem · 1

    DEVICE 2 OF 3. HEALTHCARE PROFESSIONAL REPORTS OUT OF RANGE HIGH CITRATED PT RESULTS WERE GENERATED WITH THREE DIFFERENT HEMOCHRON JR. SIGNATURE PLUS MICROCOAGULATION SYSTEMS FOR THE SAME PT. NO INFORMATION WAS PROVIDED AS TO WHY THE PT WAS BEING TESTED FOR PT/INR. ALL ATTEMPTS TO OBTAIN A PT/INR RESULT GENERATED OUT OF RANGE HIGH ERROR MESSAGES. SAMPLES SENT TO THE REFERENCE LABORATORY REPORTED PT/INR RESULTS AS EXPECTED. ANTICOAGULATION WAS ADJUSTED BASED ON THE LABORATORY RESULTS. DURING THE COURSE OF THERAPY, A CLOT WAS DETECTED IN THE LUMBAR CATHETER. THE PT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT AND SUBSEQUENTLY DISCHARGED FROM THE HOSPITAL ON (B)(6) 2014. NO INFORMATION WAS RECEIVED REGARDING ASSOCIATED MEDICAL INTERVENTIONS OR PT STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360391 HEMOCHRON JR SIGNATURE PLUS SYSTEM IN VITRO COAGULATION JPA INTERNATIONAL TECHNIDYNE CORP PSIG

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Other ZOFRAN| ZANAX| ZANTAC| SENSIPAR| PHOSLO| TYLENOL WITH CODEINE| ALBUTEROL| PEPSID| ACTIVAS| HEPARIN| HEXER| AMBIEN