BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPS-1

    MDR report key: 6202031 · Received December 23, 2016

    Report

    Report Number
    6202031
    Event Type
    Malfunction
    Date Received
    December 23, 2016
    Date of Event
    December 16, 2016
    Report Date
    December 22, 2016
    Manufacturer
    ORGAN RECOVERY SYSTEMS, INC
    Product Code
    KDN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    APPROXIMATELY 6 DAYS AGO, OUR OPO (ORGAN PROCUREMENT ORGANIZATION) RECEIVED COMMUNICATION FROM (B)(6) THAT THERE WAS CONTAMINATED ORGAN PRESERVATION FLUID USED IN TRANSPLANT CASES. OUR OPO ESCALATED INFORMATION REGARDING PATIENTS AT OUR FACILITY. IMPACTED PATIENTS WERE AS FOLLOWS: WE RECEIVED A NOTIFICATION OVER THE WEEKEND THAT THERE WAS CONTAMINATED ORGAN PRESERVATION SOLUTION DISCOVERED PER THE MESSAGE FROM THE (B)(6). WE RECEIVED THE E-MAIL FROM OUR OPO (ORGAN PROCUREMENT ORGANIZATION) INFORMING US THAT THEY CHECKED THE SOLUTION BATCH NUMBERS AND DISCOVERED THAT WE USED THIS SOLUTION ON SEVERAL OF OUR PATIENTS. A TOTAL OF SIX PATIENTS AT THIS FACILITY RECEIVED ORGAN TRANSPLANTS THAT WERE AFFECTED BY THE CONTAMINATED ORGAN PRESERVATION FLUID. THE FIRST PATIENT WAS READMITTED APPROXIMATELY TWO WEEKS AFTER TRANSPLANT FOR TREATMENT OF HYDRONEPHROSIS AND CHRONIC UTIS. THE SECOND PATIENT RECEIVED ADDITIONAL MEDICATION TO COVER THE POTENTIAL INFECTION RELATED TO THE CONTAMINATED ORGAN PRESERVATION FLUID. THE THIRD PATIENT'S MEDICATIONS DURING HOSPITALIZATION AND AT DISCHARGE WERE ADJUSTED TO COVER THE ORGANISMS REPORTED IN THE CONTAMINATED ORGAN PRESERVATION FLUID. THE FOURTH PATIENT HAS NO SIGNS OF INFECTION AND HAD NO CHANGES TO THEIR PLAN OF CARE. THE FIFTH PATIENT IS BEING SEEN BY ID (INFECTIOUS DISEASE) CONSULT TEAM AND PT ON EMPIRIC THERAPY FOR THE ORGANISMS IN THE PRESERVATION SOLUTION AND POSSIBLE HCAP (HEALTH CARE ASSOCIATED PNEUMONIA).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    852466 SPS-1 SYSTEM, PERFUSION, KIDNEY KDN ORGAN RECOVERY SYSTEMS, INC PBR-0074-330

    Patients

    Seq Age Sex Outcome Treatment
    1 Other