BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOCHRON SIGNATURE ELITE WHOLE BLOOD MICROCOAGULATION SYSTEM

    MDR report key: 10017048 · Received May 1, 2020

    Report

    Report Number
    10017048
    Event Type
    Malfunction
    Date Received
    May 1, 2020
    Date of Event
    May 28, 2019
    Report Date
    April 22, 2020
    Manufacturer
    ACCRIVA DIAGNOSTICS HOLDINGS, INC.
    Product Code
    JPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PROCEDURE NURSE AND ORIENTEE REGISTERED NURSE WERE IN A STROKE ALERT 2 CASE, PERFORMING A SERIES OF ACTIVATED COAGULATION TIME (ACT) LEVELS AFTER DOSES OF HEPARIN IV BY CRNA. DR. QUESTIONED THE ACT LEVELS, SINCE THE LEVELS WERE NOT REFLECTING THE HEPARIN DOSES AS EXPECTED. DR. ASKED TO BRING IN THE OTHER ELITE ACT MACHINE FROM ANOTHER ROOM AND COMPARE TESTS. ANOTHER TEST WAS INITIATED. BOTH MACHINES AT THE SAME TIME, AND ADMINISTERED THE SAME BLOOD SAMPLE ONTO BOTH CUVETTES, WITH MAYBE 2 SECONDS IN BETWEEN. THE FIRST MACHINE READ 296SEC AND THE SECOND MACHINE READ 198SEC. POINT OF CARE TESTING DEPARTMENT WAS NOTIFIED THE NEXT MORNING, AND SHE TOOK THE 1ST MACHINE BACK TO HER DEPARTMENT TO HAVE THE MANUFACTURER INVESTIGATE THE PROBLEM. A DONOR MACHINE HAS BEEN GIVEN TO US IN THE MEANTIME. NEUROVASCULAR SURGERY WAS CONSULTED, S/P THROMBECTOMY WITH STENTING TO RIGHT INTERNAL CAROTID ARTERY (ICA) WITH DR. NEXT DAY, CT HEAD WITHOUT HEMORRHAGIC CONVERSION. FOLLOWING DAY, RESOLUTION OF SYMPTOMS, STABLE FOR TRANSFER TO NEURO FLOOR. PATIENT HAS NO NEURO DEFICIT, PATIENT EVALUATED HIM AND CLEARED TO BE DISCHARGED TO HOME, CT HEAD REPEATED WITH NO ACUTE PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    481630 HEMOCHRON SIGNATURE ELITE WHOLE BLOOD MICROCOAGULATION SYSTEM SYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES JPA ACCRIVA DIAGNOSTICS HOLDINGS, INC. ELITE

    Patients

    Seq Age Sex Outcome Treatment
    1 22995 DA