BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPS-1

    MDR report key: 6285511 · Received January 30, 2017

    Report

    Report Number
    6285511
    Event Type
    Malfunction
    Date Received
    January 30, 2017
    Date of Event
    August 30, 2016
    Report Date
    January 27, 2017
    Manufacturer
    ORGAN RECOVERY SYSTEMS, INC
    Product Code
    KDN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    RECEIVED KIDNEY FROM OPO (ORGAN PROCUREMENT ORGANIZATION), IMPLANTED IN PATIENT. APPROXIMATELY 125 DAYS AFTER IMPLANT, RECEIVED GENERAL NOTICE FROM (B)(6) REGARDING THE CONTAMINATION OF ORGAN PRESERVATION FLUID. THE FOLLOWING DAY, RECEIVED NOTICE FROM OPO THAT THEY HAD USED THE AFFECTED LOTS. TWO DAYS AFTER OPO NOTICE, RECEIVED NOTICE FROM OPO THAT ONE OF OUR PATIENT'S HAD RECEIVED KIDNEY FROM THE AFFECTED LOT OF CONTAMINATED ORGAN PRESERVATION FLUID. OUR HOSPITAL EPIDEMIOLOGISTS REVIEWED PATIENT CHART. DETERMINED THAT PATIENT COMPLICATIONS WERE NOT DUE TO CONTAMINATED FLUID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    70220 SPS-1 SYSTEM, PERFUSION, KIDNEY KDN ORGAN RECOVERY SYSTEMS, INC PBR-0060-386

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR