BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIASPAN

    MDR report key: 220858 · Received April 21, 1999

    Report

    Report Number
    2529306-1999-00004
    Event Type
    Injury
    Date Received
    April 21, 1999
    Date of Event
    January 30, 1999
    Report Date
    April 21, 1999
    Manufacturer
    DUPONT PHARMACEUTICALS CO.
    Product Code
    MFU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    INITIAL NOTIFICATION (3/22/99). ADD'L INFO (3/24/99). A 34-YR-OLD MALE EXPERIENCED HEART FAILURE FOLLOWING HEART TRANSPLANT SURGERY ON 1/30/99. THE PT'S HISTORY IS SIGNIFICANT FOR DILATATIVE CARDIOMYOPATHY. VIASPAN WAS USED FOR ORGAN PRESERVATION. HE EXPERIENCED PRIMARY HEART FAILURE AND EXTRA CORPOREAL OXYGENATION WAS NECESSARY. THE PT UNDERWENT A SECOND TRANSPLANT SURGERY WHICH WAS SUCCESSFUL. THE VIASPAN WAS NOT FILTERED AND VIASPAN WAS NOT FLUSHED FROM THE DONOR ORGAN PRIOR TO TRANSPLANTATION. THE RPTR THOUGHT THAT THERE WAS A POSSIBLE RELATIONSHIP BETWEEN THE HEART FAILURE AND VIASPAN. THE DUPONT PHARMACEUTICALS CO IS BOTH THE MFR AND DISTRIBUTOR FOR VIASPAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VIASPAN Implant GASTROENTEROLOGY AND UROLOGY PRODUCT MFU DUPONT PHARMACEUTICALS CO. NA D8 F16, D8 F25, D8 I22

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Hospitalization