BEUDAMED
    FDA Adverse Event Injury Summary report: N

    *

    MDR report key: 569244 · Received January 26, 2005

    Report

    Report Number
    569244
    Event Type
    Injury
    Date Received
    January 26, 2005
    Date of Event
    January 4, 2005
    Report Date
    January 21, 2005
    Manufacturer
    MEDTRONIC CARDIAC SURGERY
    Product Code
    DTZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    PT ON FULL BYPASS UNDERGOING AN AORTIC VALVE REPLACEMENT. PERFUSIONIST RECOGNIZED DECREASING BLOOD FLOW THROUGH OXYGENATOR AFTER 45 MINUTES. PERFUSIONIST PERFORMED EMERGENCY, STERILE REPLACEMENT OF THE OXYGENATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * OXYGENATOR DTZ MEDTRONIC CARDIAC SURGERY AFFINITY NT511 0409000730

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Life Threatening