BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPS-1

    MDR report key: 6292707 · Received January 31, 2017

    Report

    Report Number
    MW5067558
    Event Type
    Death
    Date Received
    January 31, 2017
    Date of Event
    January 15, 2017
    Report Date
    January 30, 2017
    Manufacturer
    ORGAN PRESERVATION SYSTEMS
    Product Code
    KDN
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    RECIPIENT RECEIVED ORGAN THAT HAD BEEN PRESERVED IN SPS-1 PRESERVATION FLUID, DISTRIBUTED BY (B)(4). RECIPIENT LATER WAS RE-ADMITTED WITH SEPSIS, HYPOTENSION, AND EXPIRED. STRENGTH: UNK. ROUTE: OTHER, PRESERVATION FLUID. THERAPY DATE: (B)(6) 2016. DIAGNOSIS OR REASON FOR USE: ORGAN PRESERVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    73993 SPS-1 SPS-1 KDN ORGAN PRESERVATION SYSTEMS

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Death