BEUDAMED
    FDA Adverse Event Death Summary report: N

    LEVEL 1 TECHNOLOGIES

    MDR report key: 370943 · Received January 11, 2002

    Report

    Report Number
    370943
    Event Type
    Death
    Date Received
    January 11, 2002
    Date of Event
    December 19, 2001
    Report Date
    January 11, 2002
    Manufacturer
    LEVEL 1 TECHNOLOGIES
    Product Code
    BSB
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ELDERLY PT HAVING OPEN HEART SURGERY. AIR GOT INTO RIGHT HEART CHAMBER AND CAUSED AN AIR EMBOLISM. PT WAS ON RAPID INFUSER AND C-P BYPASS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEVEL 1 TECHNOLOGIES BLOOD SOLUTION/WARMER BSB LEVEL 1 TECHNOLOGIES H250 *
    2 LEVEL 1 TECHNOLOGIES AIR COMPRESSOR BTI LEVEL 1 TECHNOLOGIES H25 *
    3 LEVEL 1 TECHNOLOGIES PRESSURE INFUSOR KZD LEVEL 1 TECHNOLOGIES H2 *

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death