BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPORT KIDNEY TRANSPORTER SYSTEM

    MDR report key: 10270732 · Received July 14, 2020

    Report

    Report Number
    3004068499-2020-00009
    Event Type
    Malfunction
    Date Received
    July 14, 2020
    Date of Event
    June 24, 2020
    Report Date
    July 14, 2020
    Manufacturer
    ORGAN RECOVERY SYSTEMS, INC.
    Product Code
    KDN
    UDI-DI
    00815045020032
    PMA / PMN Number
    K021362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION DOES NOT APPLY. THE DEVICE HAS NO PATIENT CONTACT. OUTCOMES ATTRIBUTED TO ADVERSE EVENT DO NOT APPLY. RELEVANT TESTS / LABORATORY DATA DO NOT APPLY. OTHER RELEVANT HISTORY DOES NOT APPLY. SUSPECT PRODUCT(S) DO NOT APPLY. SERIAL NUMBER DOES NOT APPLY. DEVICES IS NOT IMPLANTED; THEREFORE, IMPLANT/EXPLANT DATES DO NOT APPLY. REPROCESSOR DOES NOT APPLY. USER FACILITY / IMPORTER DOES NOT APPLY. IND DOES NOT APPLY. ADVERSE EVENT TERM(S) DO NOT APPLY. INITIAL REPORT: FOLLOW-UP TYPE DOES NOT APPLY. EXPLANATIONS FOR THE EVENT PROBLEM AND EVALUATION CODES ARE DESCRIBED BELOW. (B)(4). METHOD CODE: THE INVESTIGATOR VISUALLY INSPECTED THE RETURNED PERFUSION CIRCUIT AND FOUND THAT THE LUER CONNECTION BETWEEN THE SAMPLE PORT AND THE FILTER TUBE WAS DISCONNECTED. RESIDUE FROM PERFUSION SOLUTION COULD BE SEEN WITHIN THE THREADS OF THE LUER LOCK, PROVIDING EVIDENCE OF THE LEAKAGE. THE COMPONENTS OF THE LUER FITTING DID NOT SHOW ANY CRACKS, DEFORMATION OR DAMAGE, AND WERE TIGHTENED BY THE INVESTIGATOR IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE. THE DEVICE WAS THEN LOADED ONTO A LKT101P LIFEPORT KIDNEY TRANSPORTER AND FUNCTIONALLY TESTED, USING WATER TO SIMULATE PERFUSATE AND BLUE FOOD DYE TO AID IN IDENTIFYING THE LEAK. A LEAK WAS IDENTIFIED AT THE LUER FITTING AND THE CUSTOMER'S COMPLAINT WAS CONFIRMED. COMPLAINT DATA AND BATCH RECORDS WERE ALSO REVIEWED. CORRECTION/REMOVAL REPORTING NUMBER DOES NOT APPLY.

    Description of Event or Problem · 1

    ORGAN RECOVERY SYSTEMS (ORS) RECEIVED A CUSTOMER COMPLAINT THAT THE LKT200 LEAKED FLUID. THE TRANSPLANT CENTER DECIDED TO DISCARD THE KIDNEY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    735969 LIFEPORT KIDNEY TRANSPORTER SYSTEM PERFUSION CIRCUIT KDN ORGAN RECOVERY SYSTEMS, INC. LKT200 122194 00815045020032

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention