BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORGANOX METRA

    MDR report key: 20311017 · Received September 26, 2024

    Report

    Report Number
    3022300078-2024-00018
    Event Type
    Injury
    Date Received
    September 26, 2024
    Date of Event
    August 28, 2024
    Report Date
    September 26, 2024
    Manufacturer
    ORGANOX LIMITED
    Product Code
    QQK
    UDI-DI
    05060462240005
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    AU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A SERVICE ENGINEER (SE) EVALUATED THE DEVICE AT THE CUSTOMER SITE. THE SE REPEATED OXYGEN CONCENTRATOR TESTING SEVERAL TIMES AND MEASUREMENTS WERE NORMAL. THEY ALSO CHECKED THE AIR PUMP AND DIVERTOR VALVE FUNCTION. PERFUSION DATA WAS DOWNLOADED FROM THE DEVICE AND UPLOADED FOR REVIEW. THE DEVICE DATA WAS REVIEWED BY A MEMBER OF THE CLINICAL TEAM AND IT WAS DETERMINED THAT NO ISSUES WERE IDENTIFIED. THE ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED BASED ON THE INFORMATION AVAILABLE.

    Description of Event or Problem · 0

    THE DEVICE USER (DU) REPORTED CONCERNS WITH PO2 DISCREPANCY BETWEEN THE METRA AND THEIR BLOOD GAS DEVICE ONE HOUR INTO THE PERFUSION. WHILE TROUBLESHOOTING WAS BEING COMPLETED, IT APPEARED THAT THE ISSUE MIGHT BE A FLUCTUATING PO2 WHICH GAVE THE APPEARANCE OF A DIFFERENCE. IT WAS CONFIRMED THE FLOWS WERE STABLE. THE DU PLOTTED THE PO2 ON THE GRAPHICAL USER INTERFACE (GUI) TO CONFIRM HISTORICAL PO2 LEVELS WHICH SHOWED LOTS OF VARIATION. AN IMAGE OF THE GUI SHOWED FOUR PERCENT O2 DELIVERY TO THE LIVER. A MANUAL CALIBRATION WAS COMPLETED WHICH SHOWED A SMALL OFFSET OF 12KPA TO 7KPA WHICH THE DU WAS PLEASED WITH. HOWEVER, SUBSEQUENTLY THE DU REACHED OUT AGAIN TO REPORT THAT THE INSTABILITY OF PO2 RETURNED. THE LIVER WAS DISCARDED BECAUSE VIABILITY CRITERIA WAS NOT MET. IN PARTICULAR, LACTATE INCREASED DRASTICALLY AFTER AN INITIAL DROP BEFORE THE OXYGENATION ISSUE. IN ADDITION, BILIARY PARAMETERS WORSENED TOWARDS THE END OF PERFUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1292042 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