BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORGANOX METRA

    MDR report key: 20207843 · Received September 12, 2024

    Report

    Report Number
    3011560054-2024-00081
    Event Type
    Injury
    Date Received
    September 12, 2024
    Date of Event
    August 14, 2024
    Report Date
    September 13, 2024
    Manufacturer
    ORGANOX LIMITED
    Product Code
    QQK
    UDI-DI
    05060462240005
    PMA / PMN Number
    P200035
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    EVENT DATA FROM THE DEVICE WAS RETRIEVED AND REVIEWED. EVIDENCE OF DOWNWARD TRENDING FLOWS BEGINNING ABOUT ONE HOUR INTO THE CASE WAS IDENTIFIED. HOWEVER, ROOT CAUSE OF THE ISSUE COULD NOT BE DETERMINED FROM THE DATA REVIEW. A SERVICE ENGINEER EVALUATED THE DEVICE AT THE CUSTOMER SITE. THE DEVICE WAS TESTED IN BOTH PREPARATION AND LIVER ON BOARD MODE. THE DEVICE CONSISTENTLY MAINTAINED AND REGULATED PRESSURES AND FLOW RATES AS EXPECTED. THE DEVICE PASSED ALL TESTING COMPLETED.

    Additional Manufacturer Narrative · 0

    EVENT DATA FROM THE DEVICE WAS RETRIEVED AND REVIEWED. EVIDENCE OF DOWNWARD TRENDING FLOWS BEGINNING ABOUT ONE HOUR INTO THE CASE WAS IDENTIFIED. HOWEVER, ROOT CAUSE OF THE ISSUE COULD NOT BE DETERMINED FROM THE DATA REVIEW. A SERVICE ENGINEER EVALUATED THE DEVICE AT THE CUSTOMER SITE. THE DEVICE WAS TESTED IN BOTH PREPARATION AND LIVER ON BOARD MODE. THE DEVICE CONSISTENTLY MAINTAINED AND REGULATED PRESSURES AND FLOW RATES AS EXPECTED. THE DEVICE PASSED ALL TESTING COMPLETED.

    Description of Event or Problem · 0

    THE DEVICE USER REPORTED ARTERIAL FLOW WAS LOW. INITIALLY THE DEVICE WAS PERFUSING AS THEY EXPECTED, BUT SEVERAL HOURS INTO THE PERFUSION THE ARTERIAL FLOW BEGAN TO TAPER OFF (FROM 0.4L/MIN TO 0.1 L/MIN). THEY DID VARIOUS TROUBLESHOOTING TECHNIQUES TO NO AVAIL. AS A RESULT, THE LIVER WAS DISCARDED.

    Description of Event or Problem · 0

    THE DEVICE USER REPORTED ARTERIAL FLOW WAS LOW. INITIALLY THE DEVICE WAS PERFUSING AS THEY EXPECTED, BUT SEVERAL HOURS INTO THE PERFUSION THE ARTERIAL FLOW BEGAN TO TAPER OFF (FROM 0.4L/MIN TO 0.1 L/MIN). THEY DID VARIOUS TROUBLESHOOTING TECHNIQUES TO NO AVAIL. AS A RESULT, THE LIVER WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    622041 ORGANOX METRA NORMOTHERMIC MACHINE PERFUSION SYSTEM FOR THE PRESERVATION OF DONOR LIVERS PRIOR QQK ORGANOX LIMITED 05060462240005

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other