BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPS-1

    MDR report key: 6303625 · Received February 3, 2017

    Report

    Report Number
    MW5067678
    Event Type
    Injury
    Date Received
    February 3, 2017
    Date of Event
    April 19, 2016
    Report Date
    February 2, 2017
    Manufacturer
    ORGAN RECOVERY SYSTEMS
    Product Code
    KDL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THIS IS A PT THAT RECEIVED A DECEASED DONOR TRANSPLANT ON (B)(6) 2016 AND HAD A FUNGAL INFECTION THAT REQUIRED EXPLANT OF THE TRANSPLANTED ORGAN IN (B)(6) 2016. OUR CENTER RECENTLY RECEIVED NOTIFICATION FROM UNOS REGARDING A CONTAMINATED SPS SOLUTION THAT APPLIES TO THIS CASE. THIS IS THE NOTIFICATION RECEIVED: 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." PLEASE TAKE THE FOLLOWING ACTIONS TO REPORT ADVERSE EVENTS OCCURRING ON OR AFTER (B)(6) 2016, IN PTS WHO RECEIVED ORGANS OR TISSUES FROM ORGAN RECOVERY PROCEDURES USING SPS-1 FROM ANY MANUFACTURING LOT FILE A REPORT WITH FDA'S MEDWATCH SAFETY INFO AND ADVERSE EVENT REPORTING. THERAPY START DATE: (B)(6) 2016. THERAPY END DATE: (B)(6) 2016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84600 SPS-1 SPS-1 KDL ORGAN RECOVERY SYSTEMS

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Hospitalization| S