BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEMOCHRON ACT-LR TEST

    MDR report key: 14473391 · Received May 23, 2022

    Report

    Report Number
    0002250033-2022-00001
    Event Type
    Death
    Date Received
    May 23, 2022
    Date of Event
    April 15, 2022
    Report Date
    April 18, 2022
    Manufacturer
    ACCRIVA DIAGNOSTICS, INC.
    Product Code
    JBP
    UDI-DI
    10711234103081
    PMA / PMN Number
    K960749
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS MDR REFERENCES ACCRIVA DIAGNOSTICS' COMPLAINT NUMBER (B)(4) FOR THE HEMOCHRON JACT-LR CUVETTE LOT K1JLR265. HEMOCHRON SIGNATURE ELITE INSTRUMENT (B)(4) WAS USED DURING THE PROCEDURE. THE CUVETTE HAS A LABELED EXPIRATION DATE OF 01/31/2023. HISTORICAL DATA ANALYSIS AND ANALYSIS OF PRODUCTION RECORDS DID NOT PROVIDE ANY INFORMATION RELEVANT TO THIS COMPLAINT. RETAIN SAMPLES OF THE SAME LOT OF THE DEVICE WERE TESTED AND PERFORMED WITHIN EXPECTATIONS. COMMUNICATION / INTERVIEWS WERE CONDUCTED WITH HEALTHCARE PROFESSIONALS INVOLVED IN THE CATHETERIZATION PROCEDURE. NONE OF THEIR RESPONSES INDICATED A CONNECTION BETWEEN THE PERFORMANCE OF THE JACT-LR CUVETTE OR THE HEMOCHRON SIGNATURE ELITE INSTRUMENT AND THE DEATH OF THE PATIENT. COMPLAINT ALLEGED TO THE DEVICE WERE INVESTIGATED BY TESTING RETAIN SAMPLES OF THE SAME DEVICE AND THE SAME LOT. THE INVESTIGATION FOUND NO DEVICE PROBLEM AND CONCLUDED NO PROBLEM WAS DETECTED. ACCRIVA DIAGNOSTICS HAS REQUESTED ALL DATA REQUIRED FOR FORM 3500A.

    Description of Event or Problem · 0

    (B)(6) MALE WITH ADVANCED CIRRHOSIS OF THE LIVER WAS UNDERGOING A DIAGNOSTIC CARDIAC CATHETERIZATION AND CORONARY ARTERY STENT PLACEMENT PRIOR TO A SCHEDULED LIVER TRANSPLANT. A 7,000 UNIT BOLUS DOSE OF HEPARIN WAS ADMINISTERED BEFORE THE PROCEDURE BEGAN. THE TARGET ACT TARGET RANGE WAS >250 SECONDS. FIFTEEN MINUTES LATER THE INITIAL ACT READING WAS OUT OF RANGE LOW. AN 8,000 UNIT BOLUS OF HEPARIN WAS ADMINISTERED AND THE SECOND ACT READING 4 MINUTES LATER WAS OUT OF RANGE HIGH. NO FURTHER ACT TESTING WAS DONE AND THE PROCEDURE WAS COMPLETED. FOLLOWING THE PROCEDURE, THE PATIENT HAD LOW PLATELET COUNT, PROLONGED PT/INR AND LOW HEMATOCRIT. BLOOD PRODUCTS WERE TRANSFUSED, AFTER WHICH THE PATIENT PASSED AWAY. ALL HEALTHCARE PROFESSIONALS INVOLVED IN THE PROCEDURE WERE INTERVIEWED. THE INVESTIGATION CONCLUDED THAT DEATH OF THE PATIENT WAS NOT RELATED TO DEVICE PERFORMANCE ISSUES WITH THE HEMOCHRON SIGNATURE ELITE ANALYZER OR LOW-RANGE ACT TEST DEVICE. THE RESULTS OF QUALITY CONTROLS WERE ALSO REVIEWED. QC RESULTS FROM BOTH ELECTRONIC AND LIQUID QUALITY CONTROLS DEMONSTRATED PASSING RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    526883 HEMOCHRON ACT-LR TEST ACTIVATED WHOLE BLOOD CLOTTING TIME JBP ACCRIVA DIAGNOSTICS, INC. JACT-LR K1JLR265 10711234103081

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male Death HEMOCHRON SIGNATURE ELITE, SERIAL NUMBER (B)(4)