BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPORT KIDNEY TRANSPORTER SYSTEM

    MDR report key: 9968372 · Received April 16, 2020

    Report

    Report Number
    3004068499-2020-00006
    Event Type
    Malfunction
    Date Received
    April 16, 2020
    Date of Event
    March 30, 2020
    Report Date
    April 16, 2020
    Manufacturer
    ORGAN RECOVERY SYSTEMS, INC.
    Product Code
    KDN
    UDI-DI
    00815045020025
    PMA / PMN Number
    K021362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    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. DEVICE 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.

    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
    433351 LIFEPORT KIDNEY TRANSPORTER SYSTEM PERFUSION CIRCUIT KDN ORGAN RECOVERY SYSTEMS, INC. LKT200 78072228 00815045020025

    Patients

    Seq Age Sex Outcome Treatment
    1