BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SECHRIST INDUSTRIES, INC.

    MDR report key: 12099369 · Received July 1, 2021

    Report

    Report Number
    12099369
    Event Type
    Malfunction
    Date Received
    July 1, 2021
    Date of Event
    May 28, 2021
    Report Date
    June 22, 2021
    Product Code
    BZR
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE BLENDER ON THE EXTRACORPOREAL MEMBRANE OXYGENATION MACHINE PROVIDES OXYGEN TO THE OXYGENATOR. THE PATIENT WAS CANNULATED AND THE POST ARTERIAL BLOOD GAS (ABG) MEASUREMENT NORMALLY RUN GREATER THAN 400. THIS POST ABG REMAINED IN THE HIGH 180'S. THE PATIENT DESATURATED AND REQUIRED MORE VENTILATION SUPPORT. AFTER SWITCHING OUT THE BLENDERS, THE PATIENT POST ABG WAS MORE IN THE NORMAL RANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    995151 SECHRIST INDUSTRIES, INC. MIXER, BREATHING GASES, ANESTHESIA INHALATION BZR

    Patients

    Seq Age Sex Outcome Treatment
    1 20805 DA