BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPS-1

    MDR report key: 6208988 · Received December 23, 2016

    Report

    Report Number
    MW5066922
    Event Type
    Malfunction
    Date Received
    December 23, 2016
    Date of Event
    December 1, 2016
    Report Date
    December 23, 2016
    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

    LIVEON NY OBTAINED 125 UNITS OF ORGAN RECOVERY SYSTEMS SPS-1 WITH LOT NUMBERS THAT WERE PART OF A VOLUNTARY REMOVAL (PBR-0060-392 RECEIVED ON (B)(6) 2016, PBR-0074-330 RECEIVED ON (B)(6) 2016). IN AN ABUNDANCE OF CAUTION. LIVEON NOTIFIED EVERY TRANSPLANT CENTER AND TISSUE BANK RECEIVING ORGANS AND TISSUES FROM ANY ORGAN DONOR DURING THAT TIME. (B)(6) TRANSPLANTED THE HEART FROM THE DONOR IN THIS REPORT. UPON NOTIFICATION ABOUT THE SPS-1, THEY NOTIFIED LIVEON NY AND UNOS THAT THEIR HEART RECIPIENT HAD A POSITIVE WOUND CULTURE FOR CANDIDA ALBICANS. WHILE THIS IS NOT THE SAME ORGANISM FOUND IN THE SOLUTION CULTURES, THE FINAL CONFIRMATORY CULTURES HAVE NOT BEEN REPORTED AT THIS TIME. THIS REPORT IS BASED ON THE POSSIBILITY OF USE OF ONE OF THE EFFECTED LOT NUMBERS, BUT USE OF THAT LOT NUMBER CANNOT BE CONFIRMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    852861 SPS-1 ORGAN PRESERVATION SOLUTION KDL ORGAN RECOVERY SYSTEMS PBR-0060-392
    852862 SPS-1 ORGAN PRESERVATION SOLUTION KDL ORGAN RECOVERY SYSTEMS PBR-0074-330
    852863 SPS-1 ORGAN PRESERVATION SOLUTION KDL ORGAN RECOVERY SYSTEMS PBR-0060-397

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Other