BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEART LUNG BYPASS UNIT

    MDR report key: 19429 · Received February 6, 1995

    Report

    Report Number
    MW1005019
    Event Type
    Death
    Date Received
    February 6, 1995
    Date of Event
    January 16, 1995
    Report Date
    January 24, 1995
    Manufacturer
    MEDTRONIC BIO-MEDICUS, INC.
    Product Code
    DTQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING CARDIAC SURGERY WITH PT ON HEART-LUNG BYPASS MACHINE THERE WAS A DECREASE IN VOLUME. AIR AND PRESSURE NOTED IN VENOUS LINE. ARTERIAL LINE WAS CLAMPED, PUMP SHUT OFF, AND VENOUS LINE WAS UNHOOKED. LINE REFILLED WITH SALINE. PT PUT BACK ON BYPASS MACHINE. CASE WAS COMPLETED. PT REMAINED IN A COMATOSE STATE UNTIL DEATH ON 1/23/95.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEART LUNG BYPASS UNIT HEART LUNG BYPASS UNIT DTQ MEDTRONIC BIO-MEDICUS, INC. 540

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Death