BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CELSIOR

    MDR report key: 4092239 · Received August 20, 2014

    Report

    Report Number
    2950168-2014-12601
    Event Type
    Injury
    Date Received
    August 20, 2014
    Report Date
    August 14, 2014
    Manufacturer
    GENZYME POLYCLONALS S.A.S.
    Product Code
    MSB
    PMA / PMN Number
    K991594
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SERIOUSNESS CRITERIA: MEDICAL SIGNIFICANT. PHARMACOVIGILANCE COMMENT: (B)(4) COMMENT DATED (B)(4) 2014: THIS CASE CONCERNS (B)(6) PTS WHO DEVELOPED DELAYED GRAFT FUNCTION AFTER UNDERGOING HEART TRANSPLANTATIONS AFTER USING CELSIOR ORGAN PRESERVATION SOLUTION FOR ORGAN PRESERVATION. ALTHOUGH THE ROLE OF THE ORGAN PRESERVATION SOLUTION CANNOT BE RULED OUT BASED ON THE DEVICE EVENT TEMPORAL RELATIONSHIP; HOWEVER, LACK OF DETAILED INFORMATION ABOUT MEDICAL HISTORY, LAB DATA, ANY CONCURRENT MEDICAL ILLNESSES, CLINICAL COURSE ETC. OF THE PT PRECLUDES A COMPREHENSIVE ASSESSMENT IN THIS CASE.

    Description of Event or Problem · 1

    THIS UNSOLICITED DEVICE CASE FROM UNITED STATES WAS RECEIVED ON (B)(6) 2014 FROM OTHER HEALTH CARE PROFESSIONAL. THIS CASE HAS BEEN CROSS REFERRED WITH CASE (B)(4) (CLUSTER). THIS CASE INVOLVES 5 PTS WHO EXPERIENCED DELAYED GRAFT FUNCTION AFTER UNDERGOING HEART TRANSPLANTATIONS, WHICH WERE PRESERVED WITH CELSIOR ORGAN PRESERVATION SOLUTION (CELSIOR). NO PAST DRUGS, MEDICAL HISTORY, CONCURRENT CONDITIONS OR CONCOMITANT MEDICATIONS WERE REPORTED. ON UNK DATES, THE HEARTS FOR TRANSPLANT WERE PRESERVED IN CELSIOR, SOLUTION FOR ORGAN PRESERVATION. ON UNK DATES, THE PTS UNDERWENT HEART TRANSPLANT. ON UNK DATES, AFTER AN UNSPECIFIED LATENCY PERIOD, THE PTS HAD DELAYED GRAFT FUNCTION. IT WAS REPORTED THAT THE PTS EXPECTED TO HAVE GOOD OUTCOMES BUT THEY DID NOT. NO CORRECTIVE TREATMENT WAS REPORTED. OUTCOME: UNK. A PHARMACEUTICAL TECHNICAL COMPLAINT (PTC) WAS INITIATED AND THE RESULTS WERE PENDING FOR THE SAME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    500687 CELSIOR ORGAN PRESERVATION SOLUTION MSB GENZYME POLYCLONALS S.A.S. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 CON MEDS| PREV MEDS