BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SECHRIST INDUSTRIES INC.

    MDR report key: 23342249 · Received October 20, 2025

    Report

    Report Number
    2020676-2025-00025
    Event Type
    Malfunction
    Date Received
    October 20, 2025
    Date of Event
    September 4, 2025
    Report Date
    October 20, 2025
    Manufacturer
    SECHRIST INDUSTRIES INC.
    Product Code
    DTX
    UDI-DI
    00899660002345
    PMA / PMN Number
    K023745
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A GETINGE FIELD SERVICE TECHNICIAN WAS SENT FOR INVESTIGATION AND REPAIR ON 2025-09-29. THE SECHRIST GAS MIXER WAS REPLACED. THE AIR-OXYGEN MIXER MUST BE REPLACED WITH A NEW ONE. THE AIR-OXYGEN MIXER IS UNSUITABLE FOR CLINICAL USE. THE REPORTED FAILURE DID NOT CAUSE OR CONTRIBUTE TO SERIOUS INJURY OR DEATH. SINCE NO SYSTEMIC ISSUE WAS DETERMINED NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. 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 FILE NO. (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BLOOD HAS ENTERED THE GAS MIXER. NO HARM TO ANY PERSON WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2452412 SECHRIST INDUSTRIES INC. GAS CONTROL UNIT, CARDIOPULMONARY BYPASS DTX SECHRIST INDUSTRIES INC. 3500CP-G 00899660002345

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown