BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPS PRESERVATION SOLUTION

    MDR report key: 6249038 · Received January 11, 2017

    Report

    Report Number
    MW5067191
    Event Type
    Injury
    Date Received
    January 11, 2017
    Date of Event
    January 8, 2017
    Report Date
    January 11, 2017
    Manufacturer
    ORGAN RECOVERY SYSTEMS
    Product Code
    KDN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    I'M NOT SURE IF THIS HAS BEEN REPORTED, IN DISCUSSION LAST NIGHT I WAS INFORMED BY MY TEAM THAT IN AN ORGAN PROCUREMENT PERFORMED THIS WEEKEND (B)(6) THAT THE PRESERVATION SOLUTION WAS FOUL SMELLING WHEN THE BAGS WERE OPENED, CULTURES OF THE PRESERVATION SOLUTION WERE OBTAINED AND HAVE GROWN GRAM NEGATIVE RODS PER OUR OPO LIFEGIFT THE LOT NUMBERS FOR THE SPS SOLUTION ARE PBR-0060-386 AND PBR-0074-332 OUR PT (LIVER TRANSPLANT) IS DOING WELL CURRENTLY AND THE ORGAN WAS "WASHED" WITH ANTIBIOTIC CONTAINING BEFORE REPACKAGING AND TRANSPLANT. THIS EVENT OBVIOUSLY IS SIMILAR TO THE EVENTS OF (B)(6) INVOLVING A RECALL OF THIS SOLUTION ARE QUITE CONCERNING REGARDING THE SAFETY OF THE SOLUTION. PLEASE CALL IF YOU HAVE QUESTIONS. (B)(6). THERAPY START DATE: (B)(6) 2017. THERAPY END DATE: (B)(6) 2017. DIAGNOSIS OR REASON FOR USE: PRESERVATION SOLUTION FOR ORGAN TRANSPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27544 SPS PRESERVATION SOLUTION SPS PRESERVATION SOLUTION KDN ORGAN RECOVERY SYSTEMS PBR-0060-386, P
    27545 SPS PRESERVATION SOLUTION SPS PRESERVATION SOLUTION KDN ORGAN RECOVERY SYSTEMS PBR-0074-332

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR SPS-1