BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPS-1

    MDR report key: 6275635 · Received January 24, 2017

    Report

    Report Number
    MW5067422
    Event Type
    Malfunction
    Date Received
    January 24, 2017
    Date of Event
    January 9, 2017
    Report Date
    January 20, 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

    (B)(6) OBTAINED 125 UNITS OF ORGAN RECOVERY SYSTEMS SPS-1 WITH LOT NUMBERS THAT WERE PART OF A VOLUNTARY REMOVAL (PBR-0060-392 RECEIVED 08/25/2016, PBR-0074-330 RECEIVED 10/11/2016). IN AN ABUNDANCE OF CAUTION, (B)(6) NOTIFIED EVERY TRANSPLANT CENTER AND TISSUE BANK RECEIVING ORGANS AND TISSUES FROM ANY ORGAN DONOR DURING THAT TIME. THE LIVER/KIDNEY RECIPIENT FROM THIS DONOR HAS BEEN SPIKING FEVERS SINCE TRANSPLANT ON (B)(6) 2016. TRANSPLANT CENTER REPORTED TO OPO BECAUSE OF POSSIBLE USE OF POTENTIALLY CONTAMINATED SPS-1 SOLUTION IN DONOR. THERAPY START DATE: (B)(6) 2016. THERAPY END DATE: (B)(6) 2016. DIAGNOSIS OR REASON FOR USE: ROUTINE FLUSH OF DONOR ORGANS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58163 SPS-1 SPS-1 KDL ORGAN RECOVERY SYSTEMS PBR-0060-392
    58164 SPS-1 SPS-1 KDL ORGAN RECOVERY SYSTEMS PBR-0074-330

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR