BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPS-1 (HTTP://WWW.ORG-AN-RECOVERY)

    MDR report key: 6199789 · Received December 22, 2016

    Report

    Report Number
    MW5066872
    Event Type
    Injury
    Date Received
    December 22, 2016
    Date of Event
    November 19, 2016
    Report Date
    December 21, 2016
    Manufacturer
    ORGAN RECOVERY SYSTEMS
    Product Code
    KDL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PT RECEIVED A KIDNEY AND PANCREAS TRANSPLANT AT (B)(6) FROM A DONOR RECOVERED BY (B)(6) USING A PRESERVATION SOLUTION SUBSEQUENTLY RECALLED BY THE FDA FOR POSSIBLE BACTERIAL CONTAMINATION: SPS-1 (HTTP://WWW.ORGAN-RECOVERY.COM). PBR-0074-330, EXPIRATION 07/01/2018; PBR-0060-392, EXPIRATION 06/01/2018. THE PT DEVELOPED A FEBRILE ILLNESS MARKED BY A LEUKOCYTOSIS OF 30,000. MULTIPLE CULTURES OF DIFFERENT BODY FLUIDS WERE NEGATIVE, BUT THE PT WAS ON BROAD SPECTRUM ANTIBIOTICS. SHE HAS SUBSEQUENTLY DONE WELL BUT HAD A DIFFICULT 20 DAY HOSPITALIZATION AND REQUIRED REOPERATION AFTER THE INITIAL TRANSPLANT OPERATION. THERAPY START DATE: (B)(6) 2016. THERAPY END DATE: (B)(6) 2016. DIAGNOSIS OR REASON FOR USE: ORGAN RECOVERY. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED? YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    850965 SPS-1 (HTTP://WWW.ORG-AN-RECOVERY) STATIC PRESERVATION SOLUTION KDL ORGAN RECOVERY SYSTEMS PBR-0074-330
    850966 SPS-1 (HTTP://WWW.ORG-AN-RECOVERY) STATIC PRESERVATION SOLUTION KDL ORGAN RECOVERY SYSTEMS PBR-0060-392

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization