BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORGANOX METRA

    MDR report key: 20284978 · Received September 23, 2024

    Report

    Report Number
    3011560054-2024-00084
    Event Type
    Malfunction
    Date Received
    September 23, 2024
    Date of Event
    August 26, 2024
    Report Date
    September 23, 2024
    Manufacturer
    ORGANOX LIMITED
    Product Code
    QQK
    UDI-DI
    05060462240005
    PMA / PMN Number
    P200035
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A SERVICE ENGINEER (SE) EVALUATED THE DEVICE AT THE CUSTOMER SITE. THE SE REPLACED THE LOOSE COLDER PRODUCTS COMPANY (CPC) CONNECTOR ON THE WATER CIRCUIT WITH A NEW CONNECTOR AND GASKET. THE DEVICE TESTED SUCCESSFULLY WITH NO LEAKS AFTERWARDS. A CORRECTIVE AND PREVENTATIVE ACTION (CAPA) WAS INITIATED TO FURTHER INVESTIGATE THIS ISSUE. THE ROOT CAUSE OF THE ISSUE IS SUSPECTED TO BE RELATED TO THE MANUFACTURING PROCEDURE NOT PROVIDING CLEAR TORQUING INSTRUCTIONS, SUCH AS THE PROPER TORQUING FORCES AND PROPER TOOLS FOR CONNECTIONS. DETAILED TORQUING SPECIFICATIONS WILL BE ADDED TO THE MANUFACTURING DRAWINGS AND PROCEDURES USED IN ASSEMBLING THE CONNECTORS. ADDITIONALLY, THE PROPER TOOLING NEEDED TO MEET TORQUING SPECIFICATIONS WILL BE CLARIFIED WITHIN THE MANUFACTURING DRAWINGS AND PROCEDURES.

    Description of Event or Problem · 0

    THE DEVICE USER (DU) REPORTED THAT THERE WAS A LOOSE WATER CONNECTION ON THE DEVICE. THEY WERE ASKED TO ENSURE IT WAS PROPERLY HEATING PERFUSATE AND THEY CONFIRMED THAT IT WAS WORKING FINE AT THE TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1691525 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