BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORGANOX METRA

    MDR report key: 24160251 · Received January 23, 2026

    Report

    Report Number
    3011560054-2025-00169
    Event Type
    Malfunction
    Date Received
    January 23, 2026
    Date of Event
    December 29, 2025
    Report Date
    February 19, 2026
    Manufacturer
    ORGANOX LIMITED
    Product Code
    QQK
    UDI-DI
    5060462240005
    PMA / PMN Number
    P200035
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE WAS SERVICED AT THE CUSTOMER SITE BY A FIELD SERVICE ENGINEER. DURING TESTING, THE ISSUE WAS UNABLE TO BE REPRODUCED. THE IFB BOARD AND FLOW SENSOR WERE REPLACED PRE-EMPTIVELY. THE DEVICE SUBSEQUENTLY PASSED ALL APPLICABLE TESTING.

    Additional Manufacturer Narrative · 0

    REVIEW OF THE PERFUSION DATA FOUND THAT IT WAS LIKELY THAT AN IFB TIMEOUT CAUSED THE MESSAGE CODE 240 (PORTAL FLOW SENSOR FAULT). DATA SUGGESTS THAT A PERFUSION STOP AND DEVICE RESTART WAS INITIATED BY THE DEVICE USER WHICH CAUSED AND/OR COINCIDED WITH THE RESOLUTION OF BOTH. THE PORTAL FLOW SENSOR AND THE IFB WERE RETURNED FOR INVESTIGATION. BOTH APPEARED UNDAMAGED DESPITE EVIDENCE OF PERFUSATE ON THE FLOW SENSOR. THE ROOT CAUSE OF THE REPORTED FLOW SENSOR ISSUE WAS AN IFB RESET.

    Description of Event or Problem · 0

    AT THE START OF PERFUSION, THE DEVICE USER OBSERVED AN ISSUE WITH THE FLOW SENSORS, WHICH WAS SUCCESSFULLY RESOLVED THROUGH TROUBLESHOOTING. HOWEVER, SEVERAL HOURS LATER, THE DEVICE TRIGGERED ALARM 240 (PORTAL FLOW SENSOR ERROR). THE LIVER WAS SUCCESSFULLY TRANSFERRED TO ANOTHER METRA DEVICE. FOLLOWING PERFUSION, THE LIVER WAS DECLINED DUE TO POOR GRAFT QUALITY AND AN UNFAVORABLE VIABILITY ASSESSMENT.

    Description of Event or Problem · 0

    AT THE START OF PERFUSION, THE DEVICE USER OBSERVED AN ISSUE WITH THE FLOW SENSORS, WHICH WAS SUCCESSFULLY RESOLVED THROUGH TROUBLESHOOTING. HOWEVER, SEVERAL HOURS LATER, THE DEVICE TRIGGERED ALARM 240 (PORTAL FLOW SENSOR ERROR). THE LIVER WAS SUCCESFULLY TRANSFERRED TO ANOTHER METRA DEVICE. FOLLOWING PERFUSION, THE LIVER WAS DECLINED DUE TO POOR GRAFT QUALITY AND AN UNFAVORABLE VIABILITY ASSESSMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221594 ORGANOX METRA NORMOTHERMIC MACHINE PERFUSION SYSTEM FOR THE PRESERVATION OF DONOR LIVERS PRIOR QQK ORGANOX LIMITED 5060462240005

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown