BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SECHRIST INDUSTRIES INC.

    MDR report key: 23759634 · Received December 9, 2025

    Report

    Report Number
    2020676-2025-00030
    Event Type
    Malfunction
    Date Received
    December 9, 2025
    Date of Event
    November 12, 2025
    Report Date
    December 9, 2025
    Manufacturer
    SECHRIST INDUSTRIES
    Product Code
    DTX
    UDI-DI
    00899660002345
    PMA / PMN Number
    K023745
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED ISSUE OF UNABLE TO OXYGENATE WAS CONFIRMED. THE RETURNED MIXER HAD PREVIOUSLY BEEN SERVICED BY A THIRD PARTY. DURING EVALUATION, THE FIO2 KNOB WAS FOUND TO BE LOOSE AND DETACHED, AND THE BALANCE WAS OUTSIDE THE SPECIFIED LIMITS. THE MOST LIKELY ROOT CAUSE IS INADEQUATE SERVICING OF THE DEVICE. AT THIS TIME THERE IS NO EVIDENCE THAT A MANUFACTURING NON-CONFORMITY CONTRIBUTED TO THE REPORTED COMPLAINT, AND THE INSTRUCTIONS FOR USE WERE REVIEWED AND DETERMINED TO PROVIDE ADEQUATE INSTRUCTIONS AND WARNINGS FOR THE SAFE AND EFFECTIVE USE OF THE DEVICE. THE IFU STATES, "TO ENSURE PROPER FUNCTION AND ACCURACY, THE SECHRIST AIR/OXYGEN GAS MIXERS MUST BE THOROUGHLY OVERHAULED EVERY TWO (2) YEARS. TO MAINTAIN THE PRODUCT WARRANTY, THE OVERHAUL MUST BE PERFORMED BY SECHRIST INDUSTRIES OR BY SECHRIST AUTHORIZED PERSONNEL." THEREFORE, NO CORRECTIVE OR PREVENTATIVE ACTIONS ARE NECESSARY. ALL COMPLAINTS ARE TRENDED AND REVIEWED BY MANAGEMENT ON A MONTHLY BASIS. AS PART OF THIS MONTHLY REVIEW, ANY EXCURSION ABOVE THE CONTROL LIMITS FOR THIS FAILURE MODE WILL BE ASSESSED, DOCUMENTED AND ACTED UPON AS WARRANTED. MANUFACTURER REFERENCE NO. (B)(4).

    Description of Event or Problem · 0

    CUSTOMER REPORTED STAFF WAS ATTEMPTING TO OXYGENATE THE PATIENT WHILE HE/SHE WAS ON BYPASS AND WERE UNABLE TO. STAFF SWAPPED THE DEVICE FOR ANOTHER ONE AND IT WORKED APPROPRIATELY. NO PATIENT HARM OCCURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2720818 SECHRIST INDUSTRIES INC. GAS CONTROL UNIT, CARDIOPULMONARY BYPASS DTX SECHRIST INDUSTRIES 3500CP-G 00899660002345

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown