BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEMOCHRON¿ WHOLE BLOOD MICROCOAGULATION SYSTEM - HEMOCHRON SIGNATURE ELITE INSTR

    MDR report key: 16812022 · Received April 25, 2023

    Report

    Report Number
    0002250033-2023-00001
    Event Type
    Death
    Date Received
    April 25, 2023
    Date of Event
    January 23, 2023
    Report Date
    April 25, 2023
    Manufacturer
    ACCRIVA DIAGNOSTICS, INC.
    Product Code
    JPA
    PMA / PMN Number
    K050016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS MDR REFERENCES ACCRIVA DIAGNOSTICS' COMPLAINT NUMBER 200668135 FOR THE HEMOCHRON¿ WHOLE BLOOD MICROCOAGULATION SYSTEM - HEMOCHRON SIGNATURE ELITE INSTRUMENT SE22687. THE HEMOCHRON JACT-LR CUVETTE LOT E2JLR151 WAS USED DURING THE PROCEDURE. THE INSTRUMENT HAS NO EXPIRATION DATE. THE CUVETTE HAS A LABELED EXPIRATION DATE OF AUGUST 31, 2023. ON APRIL 4, 2023, AN ACCRIVA (WERFEN) APPLICATION SPECIALIST VISITED THE HEALTHCARE FACILITY TO INVESTIGATE THE ALLEGED HEMOCHRON SIGNATURE ELITE ANALYZER. THE SPECIALIST PERFORMED QC TESTING ON THE DEVICE IN QUESTION, THE DEVICE PASSED ALL TESTS, THE DEVICE ALSO APPEARED TO BE IN GOOD VISIBLE CONDITION AND NO VISIBLE FAULTS. THE END USER REPORTED THAT THE INSTRUMENT HAS NOT RECENTLY DISPLAYED ANY ERRORS. 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. THE DHR FOR ELITE INSTRUMENT SE22687 WAS REVIEWED AND ANALYZED FOR POTENTIAL NON-CONFORMITIES, OR ANOMALIES, WHICH COULD HAVE LED TO THIS COMPLAINT ALLEGATION. REVIEW AND ANALYSIS INDICATED NO NON-CONFORMITIES OR ANOMALIES THAT CAN BE A FACTOR OR BE A POTENTIAL ROOT CAUSE TO THE AFOREMENTIONED ALLEGATION. THE PRODUCT INITIAL RELEASE TESTING WAS FOUND TO MEET ALL SPECIFICATIONS. THE DHR FOR LOT E2JLR151 WAS REVIEWED AND ANALYZED FOR POTENTIAL NON-CONFORMITIES, OR ANOMALIES, WHICH COULD HAVE LED TO THIS COMPLAINT ALLEGATION. REVIEW AND ANALYSIS INDICATED NO NON-CONFORMITIES OR ANOMALIES THAT CAN BE A FACTOR OR BE A POTENTIAL ROOT CAUSE TO THE AFOREMENTIONED ALLEGATION. THE PRODUCT INITIAL RELEASE TESTING WAS FOUND TO MEET ALL SPECIFICATIONS. ACCRIVA DIAGNOSTICS HAS REQUESTED ALL DATA REQUIRED FOR FORM 3500A.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED THAT A HEMOCHRON SIGNATURE ELITE ANALYZER AND LOW RANGE ACT ASSAY MEASURING ACT IN THE CATHETER LAB WAS UTILIZED DURING PERCUTANEOUS CORONARY INTERVENTION (PCI) AND MAY HAVE PROVIDED ERRONEOUS RESULTS. THE PATIENT UNDERWENT SUCCESSFUL PERCUTANEOUS CORONARY INTERVENTION (PCI); HOWEVER, AFTER TRANSFER INTO CRITICAL CARE UNIT (CCU) DEVELOPED ACUTE STENT THROMBOSIS. AFTER THE PROCEDURE, THE PATIENT DEVELOPED INTRACTABLE VENTRICULAR FIBRILLATION FOLLOWING ALLEGED STENT THROMBOSIS RESULTING IN DEATH FROM REPORTED EXCESSIVE BLEEDING DUE TO PROLONGED CPR IN THE CRITICAL CARE UNIT (CCU). THE END USER EXPRESSED CONCERN THAT THE HEMOCHRON SIGNATURE ELITE USED TO MEASURE ACT INTRA-OPERATIVELY WAS POSSIBLY OVERESTIMATING THE ACT RESULT AND THUS, LEADING TO POSSIBLE UNDER HEPARINIZATION OF THE PATIENT. THE HEMOCHRON SIGNATURE ELITE ANALYZER USED TO PERFORM THE ACT TESTING WAS REMOVED FROM USE AND SENT TO THE HOSPITAL'S MEDICAL ENGINEERING DEPARTMENT. ON APRIL 4, 2023, AN ACCRIVA (WERFEN) APPLICATION SPECIALIST VISITED THE HEALTHCARE FACILITY TO INVESTIGATE THE ALLEGED HEMOCHRON SIGNATURE ELITE ANALYZER. THE SPECIALIST PERFORMED VISUAL INSPECTION, ELECTRONIC AND LIQUID QC TESTING ON THE DEVICE IN QUESTION. THE DEVICE PASSED ALL TESTS. THE DEVICE ALSO APPEARED TO BE IN GOOD VISIBLE CONDITION AND HAD NO VISIBLE FAULTS. THE END USER REPORTED THAT THE INSTRUMENT HAS NOT RECENTLY DISPLAYED ANY ERRORS. NO PATIENT INFORMATION HAS BEEN PROVIDED; THEREFORE, NO INFORMATION ON PATIENT CO-MORBIDITIES OR PATIENT HEALTH HISTORY IS AVAILABLE. THEREFORE, THERE IS INADEQUATE EVIDENCE TO SUGGEST ANALYZER WAS A DIRECT CONTRIBUTING FACTOR TOWARDS THE DEATH OF THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610399 HEMOCHRON¿ WHOLE BLOOD MICROCOAGULATION SYSTEM - HEMOCHRON SIGNATURE ELITE INSTR HEMOCHRON¿ SIGNATURE ELITE JPA ACCRIVA DIAGNOSTICS, INC. ELITEINT

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male Death ASPIRIN| HEPARIN (B)(4)UNITS @ 1243(B)(4)UNITS @ 1455| PRASUGREL