BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPORT KIDNEY TRANSPORTER SYSTEM

    MDR report key: 9678326 · Received February 6, 2020

    Report

    Report Number
    3004068499-2020-00001
    Event Type
    Malfunction
    Date Received
    February 6, 2020
    Date of Event
    January 24, 2020
    Report Date
    February 27, 2020
    Manufacturer
    ORGAN RECOVERY SYSTEMS, INC.
    Product Code
    KDN
    UDI-DI
    00815045020032
    PMA / PMN Number
    K021362
    Removal / Correction Number
    3004068499-1/30/20-001-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    CAPA-000059 HAS BEEN INITIATED TO ADDRESS THIS FAILURE MODE ASSOCIATED WITH THE REWORK OF LOT 120242. D4: UNIQUE IDENTIFIER (UDI) # HAS BEEN CORRECTED. PREVIOUS REPORT INDICATED THE DI, BUT NOT THE PI. G1: TYPE OF REPORT IS INDICATED. H2: FOLLOW-UP TYPE IS INDICATED. H3: DEVICE EVALUATED BY MANUFACTURER HAS BEEN UPDATED. H6: METHOD CODE(S), RESULT CODE(S), AND CONCLUSION CODE(S) HAVE BEEN UPDATED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION FOR THIS COMPLAINT IS CURRENTLY UNDERWAY, BUT HAS NOT YET BEEN COMPLETED. A FOLLOW-UP REPORT WILL BE FILED TO REFLECT THE RESULTS OF THE INVESTIGATION. INTERNAL DOCUMENT NUMBERS ARE (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2020, ORGAN RECOVERY SYSTEMS (ORS) RECEIVED A CUSTOMER COMPLAINT THAT THE LKT200 LEAKED FLUID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    141144 LIFEPORT KIDNEY TRANSPORTER SYSTEM PERFUSION CIRCUIT KDN ORGAN RECOVERY SYSTEMS, INC. LKT200 120242 00815045020032

    Patients

    Seq Age Sex Outcome Treatment
    1