BEUDAMED
    FDA Adverse Event Death Summary report: N

    SHILEY HEART LUNG MACHINE

    MDR report key: 36759 · Received August 8, 1996

    Report

    Report Number
    36759
    Event Type
    Death
    Date Received
    August 8, 1996
    Date of Event
    July 11, 1996
    Report Date
    July 25, 1996
    Manufacturer
    SORIN BIOMEDICAL, INC.
    Product Code
    KRL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    AIR OBSERVED IN ARTERIAL LINE AT FIELD, DURING OPEN HEART SURGERY WITH PROBABLE AIR INADVERTENTLY INJECTED OR PUMPED INTO THE AORTA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHILEY HEART LUNG MACHINE BUBBLE DETECTOR KRL SORIN BIOMEDICAL, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Death