BEUDAMED
    FDA Adverse Event Death Summary report: N

    CELSIOR

    MDR report key: 863365 · Received June 8, 2007

    Report

    Report Number
    2950168-2007-00001
    Event Type
    Death
    Date Received
    June 8, 2007
    Date of Event
    January 1, 2007
    Report Date
    May 23, 2007
    Manufacturer
    CARDINAL HEALTH
    Product Code
    MSB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS CASE REPORT 1 OF 6 FROM THIS REPORTER.

    Description of Event or Problem · 1

    HEART GRAFT VENTRICULAR DYSFUNCTION. SPONTANEOUS REPORT REC'D ON 23 MAY 2007 FROM A PHYSICIAN ASSISTANT REGARDING A HEART TRANSPLANT PT (IDENTIFIERS NOT PROVIDED). THE PT REC'D A HEART GRAFT THAT HAD BEEN PRESERVED WITH CELSIOR (DATE OF TRANSPLANT AND ELAPSED TIME OF PRESERVATION WERE NOT PROVIDED) IN 2007. THE PT'S MEDICAL HISTORY WAS NOT PROVIDED. DURING OR IMMEDIATELY POST THE HEART TRANSPLANT (ELAPSED TIME NOT PROVIDED), THE PT EXPERIENCED HEART GRAFT VENTRICULAR DYSFUNCTION AND DIED. IT WAS THE OPINION OF THE PHYSICIAN ASSISTANT THAT THE EVENT WAS SEVERE IN INTENSITY AND POSSIBLY RELATED TO CELSIOR. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CELSIOR ORGAN PRESERVATION SOLUTION MSB CARDINAL HEALTH CE138-01 OR CE149-01

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Death