BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CVR

    MDR report key: 1638655 · Received March 16, 2010

    Report

    Report Number
    1638655
    Event Type
    Injury
    Date Received
    March 16, 2010
    Date of Event
    March 12, 2010
    Report Date
    March 16, 2010
    Manufacturer
    MEDTRONIC PERFUSION SYSTEMS
    Product Code
    DTZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHILE THE PT WAS ON CARDIOPULMONARY BYPASS, THEY HAD A PROGRESSIVE WORSENING OF OXYGENATION (BY PERIPHERAL, CEREBRAL, AND PUMP MONITORS) AND A PROGRESSIVE INCREASING OF HYPERCARBIA. THE OXYGENATOR ON THE BYPASS MACHINE HAD MALFUNCTIONED. THE PUMP LINES HAD TO BE CLAMPED AND THE OXYGENATOR WAS REPLACED. THE TOTAL TIME FOR THE EXCHANGE WAS APPROXIMATELY 2.5 MINUTES. AFTER THE OXYGENATOR WAS REPLACED, THERE WAS AN IMMEDIATE IMPROVEMENT IN THE PT'S OXYGENATION, AND CO2 REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CVR OXYGENATOR, CARDIOPULMONARY DTZ MEDTRONIC PERFUSION SYSTEMS 541-R *

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention