BEUDAMED
    FDA Adverse Event Summary report: N

    CELSIOR (ORGAN PRESERVATION SOLUTION) SOLUTION FOR ORGAN PRESERVATION

    MDR report key: 2426129 · Received January 11, 2012

    Report

    Report Number
    2950168-2012-00006
    Date Received
    January 11, 2012
    Report Date
    January 6, 2012
    Manufacturer
    GENZYME POLYCLONALS S.A.S.
    Product Code
    MSB
    PMA / PMN Number
    K991594
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER'S COMMENT: NO FURTHER DETAILS WERE RECEIVED. FURTHER INFORMATION HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    ACUTE ALLOGRAFT FAILURE [COMPLICATIONS OF TRANSPLANTED HEART]. CASE DESCRIPTION: SPONTANEOUS REPORT WAS RECEIVED ON (B)(6) 2012 FROM AN OTHER HEALTH PROFESSIONAL REGARDING A PT, INITIALS UNKNOWN, WITH HEART TRANSPLANT. THE PT'S MEDICAL HISTORY WAS NOT PROVIDED. ON AN UNSPECIFIED DATE, THE PT INITIATED CELSIOR SOLUTION FOR ORGAN PRESERVATION, DOSE REGIMEN NOT PROVIDED. ON AN UNSPECIFIED DATE, THE PT EXPERIENCED ACUTE ALLOGRAFT FAILURE. THE ACTION TAKEN WITH CELSIOR TREATMENT WAS NOT PROVIDED. THE OUTCOME FOR THE EVENT OF ACUTE ALLOGRAFT FAILURE WAS UNKNOWN. CONCOMITANT MEDICATIONS WERE NOT PROVIDED. THE INTENSITY AND CAUSAL RELATIONSHIP OF THE EVENT TO CELSIOR WERE NOT PROVIDED. THIS IS 1 OF 2 CASES FROM THIS REPORTER REGARDING ACUTE ALLOGRAFT FAILURE IN PTS THAT RECEIVED THIS LOT OF CELSIOR. PLEASE REFER TO CELS-1000022 FOR THE SECOND 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