BEUDAMED
    FDA Adverse Event Death Summary report: N

    CELSIOR (ORGAN PRESERVATION SOLUTION) SOLUTION FOR ORGAN PRESERVATION

    MDR report key: 1012985 · Received March 13, 2008

    Report

    Report Number
    2950168-2008-00002
    Event Type
    Death
    Date Received
    March 13, 2008
    Date of Event
    February 1, 2008
    Report Date
    March 3, 2008
    Manufacturer
    GENZYME POLYCLONALS S.A.S.
    Product Code
    MSB
    PMA / PMN Number
    K991594
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DEATH [DEATH]. CASE DESCRIPTION: SPONTANEOUS REPORT RECEIVED ON 03 MARCH 2008 FROM A NURSE REGARDING A HEART TRANSPLANT PT (IDENTIFIERS NOT PROVIDED). THE PT RECEIVED A HEART GRAFT THAT HAD BEEN PRESERVED WITH CELSIOR (DATE OF TRANSPLANT AND ELAPSED TIME OF PRESERVATION WERE NOT PROVIDED). THE PT'S MEDICAL HISTORY WAS NOT PROVIDED. AT AN UNK TIME AFTER THE HEART TRANSPLANT, THE PT DIED (CAUSE AND DATE OF DEATH NOT PROVIDED). NO FURTHER INFO WAS PROVIDED. MFR'S COMMENT: THIS IS CASE REPORT 1 OF 3 FROM THIS REPORTER.

    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 R20102A01

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death