BEUDAMED
    FDA Adverse Event Death Summary report: N

    SECHRIST MIXER 3500CP-G

    MDR report key: 1425519 · Received July 30, 2009

    Report

    Report Number
    2020676-2009-00001
    Event Type
    Death
    Date Received
    July 30, 2009
    Date of Event
    June 7, 2009
    Report Date
    July 29, 2009
    Manufacturer
    SECHRIST INDUSTRIES, INC.
    Product Code
    BZR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WILL NOT BE SENT BACK FROM CUSTOMER. DEVICE IS AVAILABLE FOR ONSITE EVALUATION. COORDINATING WITH RISK MANAGER TO PERFORM EVALUATION OF DEVICE. FOLLOW-UP REPORT WILL BE SUBMITTED AFTER EVALUATION.

    Description of Event or Problem · 1

    HEART / LUNG BYPASS MACHINE IN USE. AIR / OXYGEN MIXER WAS A COMPONENT OF THE HEART / LUNG MACHINE. OXYGEN SUPPLY WAS INTERRUPTED. AIR / OXYGEN MIXER FAILED TO ALARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SECHRIST MIXER 3500CP-G AIR / OXYGEN BLENDER BZR SECHRIST INDUSTRIES, INC. 3500CP-G

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Death