BEUDAMED
    FDA Adverse Event Death Summary report: N

    3/8 INCH RACEWAY

    MDR report key: 594105 · Received April 20, 2005

    Report

    Report Number
    2184009-2005-00039
    Event Type
    Death
    Date Received
    April 20, 2005
    Date of Event
    March 19, 2005
    Report Date
    March 22, 2005
    Manufacturer
    MEDTRONIC PERFUSION SYSTEMS
    Product Code
    DWE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INFO RECEIVED INDICATES BLOOD LEAKED FROM THE 3/8" RACEWAY TUBING AFTER THE RACEWAY HAD BEEN WALKED DURING ECMO SUPPORT. THE PT DIED FROM COMPLICATIONS IN 2005. THE HCP HAS STATED NO DEVICE FAILURE OCCURRED AND NO EVIDENCE FOUND TO SUGGEST THE REPORTED EVENT WAS DUE TO ANY DEFECT IN THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3/8 INCH RACEWAY CUSTOM TUBING PACK DWE MEDTRONIC PERFUSION SYSTEMS 3X13R 0502001782

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death