BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SECHRIST INDUSTRIES INC.

    MDR report key: 22820312 · Received August 15, 2025

    Report

    Report Number
    2020676-2025-00020
    Event Type
    Malfunction
    Date Received
    August 15, 2025
    Date of Event
    July 21, 2025
    Report Date
    August 15, 2025
    Manufacturer
    SECHRIST INDUSTRIES INC.
    Product Code
    BZR
    UDI-DI
    00852682007491
    PMA / PMN Number
    K992503
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    EU DISTRIBUTOR INFORMING SECHRIST OF MIXER HIGHLY CONTAMINATED WITH BLOOD AND CORROSION. NO PATIENT INVOLVEMENT OR INJURY REPORTED. NEITHER CUSTOMER NOR DISTRIBUTOR REPORTED TO FDA ACCORDING TO THE INFORMATION WE HAVE AT THIS TIME. DEVICE IN QUESTION WILL NOT BE EVALUATED BY SECHRIST AS EU DISTRIBUTOR WILL EVALUATE. EU DISTRIBUTOR CONFIRMED THE DEVICE WAS CONTAMINATED WITH BLOOD INTERNALLY AND CORROSION PRESENT AS WELL. AT THIS TIME, THE REPORT IS BASED ON THE INFORMATION WE HAVE RECEIVED FROM OUR EU DISTRIBUTOR. EU DISTRIBUTOR CONCLUDED THAT USER AND ERROR AND IMPROPER CLEANING OF DEVICE TO BE THE ROOT CAUSE. SECHRIST HAS INFORMED EU DISTRIBUTOR THAT ANY DEVICES THAT HAVE BEEN CONTAMINATED INTERNALLY WITH BLOOD OR CORROSION ARE TO BE DECOMISSIONED AND NOT SERVICED. 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

    EU DISTRIBUTOR INFORMING SECHRIST OF MIXER HIGHLY CONTAMINATED WITH BLOOD AND CORROSISON. NO PATIENT INVOLVEMENT OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1180558 SECHRIST INDUSTRIES INC. MIXER, BREATHING GASES, ANESTHESIA INHALATION BZR SECHRIST INDUSTRIES INC. 3500CP-G24 00852682007491

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown