BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPS-1

    MDR report key: 6204692 · Received December 27, 2016

    Report

    Report Number
    6204692
    Event Type
    Malfunction
    Date Received
    December 27, 2016
    Date of Event
    December 21, 2016
    Report Date
    December 22, 2016
    Manufacturer
    ORGAN RECOVERY SYSTEMS, INC.
    Product Code
    KDL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS IDENTIFIED AS SOMEONE AFFECTED BY THE POTENTIALLY CONTAMINATED ORGAN PRESERVATION SOLUTION. NO HARM HAS BEEN NOTED AT THIS POINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    857052 SPS-1 ORGAN PRESERVATION FLUID KDL ORGAN RECOVERY SYSTEMS, INC. PBR0060392

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR