BEUDAMED
    FDA Adverse Event Death Summary report: N

    SECHRIST AIR/OXYGEN GAS BLENDER MODEL 3500CP-G

    MDR report key: 14847723 · Received June 28, 2022

    Report

    Report Number
    2020676-2022-00014
    Event Type
    Death
    Date Received
    June 28, 2022
    Date of Event
    June 9, 2022
    Report Date
    June 28, 2022
    Manufacturer
    SECHRIST INDUSTRIES, INC
    Product Code
    DTX
    PMA / PMN Number
    K023745
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KZ
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BASED SOLELY ON THE CUSTOMER REPORTED ISSUE OF A PATIENT DEATH WHILE IN USE WITH THE DEVICE. ADDITIONAL DEVICE AND EVENT INFORMATION WAS REQUESTED AND HAS NOT BEEN RECEIVED. PER THE CUSTOMER'S ADMISSION, THE DEVICE HAS NOT BEEN SERVICED AND WILL NOT BE RETURNED TO SECHRIST FOR EVALUATION. A DHR REVIEW FOUND 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. 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

    CUSTOMER REPORTED THERE IS NO GOOD FLOW THROUGH THE MIXER. CUSTOMER ADDED A PATIENT DIED WHILE IN USE WITH THE SECHRIST MIXER. IN ADDITION, THE CUSTOMER ADMITTED THE MIXER IS "OLD" AND MAY HAVE NOT BEEN SERVICED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2029209 SECHRIST AIR/OXYGEN GAS BLENDER MODEL 3500CP-G GAS CONTROL UNIT, CARDIOPULMONARY BYPASS DTX SECHRIST INDUSTRIES, INC 3500CP-G

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death