BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPS-1

    MDR report key: 6285497 · Received January 30, 2017

    Report

    Report Number
    6285497
    Event Type
    Malfunction
    Date Received
    January 30, 2017
    Date of Event
    November 17, 2016
    Report Date
    January 27, 2017
    Manufacturer
    ORGAN RECOVERY SYSTEMS, INC.
    Product Code
    KDL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    TRANSPLANT ADMINISTRATION RECEIVED AN EMAIL FROM THE ORGAN PROCUREMENT AGENCY THAT OUR RECIPIENT RECEIVED A LIVER GRAFT THAT WAS PERFUSED WITH A RECALLED BATCH OF ORGAN PRESERVATION SOLUTION. WE WERE MADE AWARE OF A VOLUNTARY RECALL ON CERTAIN BATCHES OF ORGAN PRESERVATION SOLUTION CALLED STATIC PRESERVATION SOLUTION -1 (SPS-1), MANUFACTURED BY ORGAN RECOVERY SYSTEMS. THE RECALL WAS DUE TO A REPORT BY ANOTHER OPO REGARDING BACTERIAL CONTAMINATION. ACCORDING TO THE REPORT THE SOLUTION SAMPLES OBTAINED FROM SEVERAL OPENED BAGS WERE POSITIVE FOR PANTOEA AGGLOMERANS AND ENTEROCOCCUS CASSELIFLAVUS. THIS MICROBIAL GROWTH WAS REPORTED FOR TWO LOTS OF THE PRESERVATION SOLUTION SPS-1, LOT: PBR-0074-330, EXPIRATION 07/01/2018 LOT: PBR-0060-392, EXPIRATION 06/01/2018. OUR PHARMACY WAS MADE AWARE OF THE RECALL SHORTLY AFTER WE RECEIVED NOTICE FROM THE FIRST OPO OVER THE WEEKEND. PHARMACY AND THE OPERATING ROOM IMMEDIATELY QUARANTINED ANY UNUSED INVENTORY FROM THE AFFECTED LOTS. OUR RECIPIENT WAS ADMITTED FOR A FEVER WORKUP.

    Description of Event or Problem · 1

    TRANSPLANT ADMINISTRATION RECEIVED AN EMAIL FROM THE ORGAN PROCUREMENT AGENCY THAT OUR RECIPIENT RECEIVED A LIVER GRAFT THAT WAS PERFUSED WITH A RECALLED BATCH OF ORGAN PRESERVATION SOLUTION. WE WERE MADE AWARE OF A VOLUNTARY RECALL ON CERTAIN BATCHES OF ORGAN PRESERVATION SOLUTION CALLED STATIC PRESERVATION SOLUTION -1 (SPS-1), MANUFACTURED BY ORGAN RECOVERY SYSTEMS. THE RECALL WAS DUE TO A REPORT BY ANOTHER OPO REGARDING BACTERIAL CONTAMINATION. ACCORDING TO THE REPORT THE SOLUTION SAMPLES OBTAINED FROM SEVERAL OPENED BAGS WERE POSITIVE FOR PANTOEA AGGLOMERANS AND ENTEROCOCCUS CASSELIFLAVUS. THIS MICROBIAL GROWTH WAS REPORTED FOR TWO LOTS OF THE PRESERVATION SOLUTION SPS-1: LOT: PBR-0074-330, EXPIRATION 07/01/2018, LOT: PBR-0060-392, EXPIRATION 06/01/2018. OUR PHARMACY WAS MADE AWARE OF THE RECALL SHORTLY AFTER WE RECEIVED NOTICE FROM THE FIRST OPO OVER THE WEEKEND. PHARMACY AND THE OPERATING ROOM IMMEDIATELY QUARANTINED ANY UNUSED INVENTORY FROM THE AFFECTED LOTS. OUR RECIPIENT WAS ADMITTED FOR A FEVER WORKUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69678 SPS-1 ORGAN PRESERVATION SOLUTION KDL ORGAN RECOVERY SYSTEMS, INC. PBR-0074-330

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR