BEUDAMED
    FDA Adverse Event Death Summary report: N

    MIXER, BIO MEDICUS

    MDR report key: 1887314 · Received October 26, 2010

    Report

    Report Number
    2020676-2010-00029
    Event Type
    Death
    Date Received
    October 26, 2010
    Date of Event
    September 21, 2010
    Report Date
    October 26, 2010
    Manufacturer
    SECHRIST INDUSTRIES, INC.
    Product Code
    BZR
    PMA / PMN Number
    K992503
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONSITE INSPECTION OF DEVICE MADE. NO FUNCTIONAL TEST PERFORMED. REQUEST SUBMITTED TO FACILITY USER TO RETURN THE DEVICE FOR INVESTIGATION AND PERFORMANCE FOR A COMPLETE FUNCTIONAL TESTS. ONCE THE TEST DATA IS PERFORMED, A FOLLOW UP REPORT SHALL BE PROVIDED.

    Description of Event or Problem · 1

    PEDIATRIC PATIENT ON EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) DIED WHILE ON PORTABLE BYPASS SYSTEM (PBS) SUPPORT. THE MIXER SOUNDED AN ALARM AND THE CONNECTIONS WERE CHECKED AS WELL AS THE DEVICE. THERE WAS ONE EVENT OF PARTIAL DE-PRIME OF THE CIRCUIT. THEN LATER, THERE WAS ANOTHER DE-PRIME AGAIN. THE CIRCUIT WAS DISASSEMBLED AND BLOOD SPRAYED ALL OVER FROM THE HIGH PRESSURE INSIDE THE LINES. REPORT THAT THE PATIENT DIED FROM A MASSIVE AIR EMBOLI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MIXER, BIO MEDICUS NONE BZR SECHRIST INDUSTRIES, INC. 20099 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death