BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPS-1

    MDR report key: 6303355 · Received February 2, 2017

    Report

    Report Number
    MW5067658
    Event Type
    Injury
    Date Received
    February 2, 2017
    Date of Event
    August 28, 2016
    Report Date
    February 2, 2017
    Manufacturer
    ORGAN RECOVERY SYSTEMS
    Product Code
    KDN
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT RECEIVED A KIDNEY TRANSPLANT ON (B)(6) 2016 THAT WAS PRESENTED IN SPS SOLUTION. PT ENDED UP WITH A FUNGAL INFECTION THAT RESULTED IN LOSING THE TRANSPLANTED KIDNEY. REPORTS TO THIS FACILITY STATED THAT THE SPS SOLUTION WAS CONTAMINATED: "BRIEF SUMMARY OF REPORT: CDC, HRSA, AND FDA ARE INVESTIGATING BACTERIAL CONTAMINATION OF SPS-1, AN ORGAN PRESERVATION SOLUTION DISTRIBUTED BY ORGAN RECOVERY SYSTEMS (ORS). DESCRIPTION: THIS IS AN UPDATE TO AN EPI-X POSTED ON (B)(6) 2017, WHICH REPORTED POTENTIAL BACTERIAL CONTAMINATION IN SPS-1 LOTS PBR-0074-337, PBR-0060-386, PBR-0074-330, AND PBR-0060-392. FDA'S INVESTIGATION OF POTENTIAL CONTAMINATION OF SEVERAL LOTS OF SPS-1, MANUFACTURED BY ORGAN RECOVERY SYSTEMS (ORS) IS ONGOING. WE RECOMMEND THAT ORGAN PROCUREMENT ORGANIZATIONS (OPO) AND TRANSPLANT FACILITIES SHOULD CONSIDER TRANSITIONING TO ALTERNATE, FDA-CLEARED ORGAN PRESERVATION FLUID PRODUCTS FROM OTHER MFRS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    79087 SPS-1 SPS-1 KDN ORGAN RECOVERY SYSTEMS

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Hospitalization| O