BEUDAMED
    FDA Adverse Event Summary report: N

    CELSIOR (ORGAN PRESERVATION SOLUTION) SOLUTION FOR ORGAN PRESERVATION

    MDR report key: 2434731 · Received January 27, 2012

    Report

    Report Number
    2950168-2012-00007
    Date Received
    January 27, 2012
    Report Date
    January 23, 2012
    Manufacturer
    GENZYME POLYCLONALS S.A.S.
    Product Code
    MSB
    PMA / PMN Number
    K991594
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MFR'S COMMENT: NO FURTHER DETAILS WERE RECEIVED. FURTHER INFO HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    ACUTE GRAFT FAILURE [GRAFT DYSFUNCTION]. CASE DESCRIPTION: SPONTANEOUS REPORT WAS RECEIVED ON (B)(6) 2012 FROM A HEALTH PROFESSIONAL REGARDING AN UNSPECIFIED TRANSPLANT PT, INITIALS NOT REPORTED. THE PT'S MEDICAL HISTORY WAS NOT PROVIDED. ON AN UNSPECIFIED DATE, THE PT INDICATED CELSIOR SOLUTION FOR ORGAN PRESERVATION, DOSE REGIMEN NOT PROVIDED. ON AN UNK DATE, TIME AFTER CELSIOR NOT REPORTED, 2 PTS HAD ACUTE GRAFT FAILURE AFTER THIS LOT OF CELSIOR WAS USED. THIS LOT WAS USED IN A TOTAL OF 3 PTS. THE OUTCOME FOR THE EVENT OF ACUTE GRAFT FAILURE WAS UNK. CONCOMITANT MEDICATIONS WERE NOT PROVIDED. THE INTENSITY AND CAUSAL RELATIONSHIP OF THE EVENT TO CELSIOR WERE NOT PROVIDED. THIS IS 1 OF 2 CASES CREATED FOR THIS REPORTED INFO. PLEASE REFER TO CELS-1000025 FOR THE OTHER CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CELSIOR (ORGAN PRESERVATION SOLUTION) SOLUTION FOR ORGAN PRESERVATION ORGAN PRESERVATION SOLUTION MSB GENZYME POLYCLONALS S.A.S. UNK CE262-02

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other