BEUDAMED
    FDA Adverse Event Death Summary report: N

    3500CP-G - MIXER 3500 LOW FLOW

    MDR report key: 10603400 · Received September 29, 2020

    Report

    Report Number
    2020676-2020-00012
    Event Type
    Death
    Date Received
    September 29, 2020
    Date of Event
    September 5, 2020
    Report Date
    September 29, 2020
    Manufacturer
    SECHRIST INDUSTRIES, INC
    Product Code
    DTX
    PMA / PMN Number
    K023745
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BASED SOLELY ON THE CUSTOMER REPORTED ISSUE. AN INCIDENT QUESTIONNAIRE WAS SENT TO THE CUSTOMER REQUESTING ADDITIONAL INFORMATION AND IT HAS NOT BEEN RETURNED. A DHR REVIEW OF THE REPORTED SERIAL NUMBER FOUND NO INDICATION THAT THERE WERE ANY RELEVANT DISCREPANCIES DURING MANUFACTURE OF THE DEVICE AND NO NON-CONFORMANCE THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. THE INSTRUCTIONS FOR USE STATE, THE LIFETIME OF SECHRIST AIR/OXYGEN MIXERS IS 20 YEARS PROVIDED THEY ARE OVERHAULED USING SECHRIST SUPPLIED COMPONENTS AND SECHRIST CERTIFIED TECHNICIANS ONCE EVERY 2 YEARS. BASED ON THE AGE OF THE DEVICE, IT APPEARS THE DEVICE HAS OUTLIVED IT'S USEFUL LIFE. 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. 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 (B)(4).

    Description of Event or Problem · 1

    FEMALE PATIENT ((B)(6)) HAD COVID AND WAS ON ECMO MACHINE FOR 5 - 8 WEEKS PRIOR TO INCIDENT. HOSPITAL FELT THE PATIENT WASN'T GETTING OXYGENATED PROPERLY SO THEY PULLED POST-OXYGENATOR RATES AND FOUND RANGE TO BE @ 50. HOSPITAL CHANGED OXYGENATORS AND THERE WAS NO CHANGE TO THE PATIENT. HOSPITAL THEN SWITCHED TO AN E TANK AND THEN RE-TESTED POST OXYGENATOR, FOUND RANGE TO BE AROUND 400. HOSPITAL CHANGED OUT THE MIXER AND RANGE THEN TESTED AT 300. HOSPITAL WITHDREW CARE 3 DAYS POST INCIDENT. PATIENT DIED AFTER CARE WAS WITHDRAWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1068559 3500CP-G - MIXER 3500 LOW FLOW GAS CONTROL UNIT, CARDIOPULMONARY BYPASS, PRODUCT CODE: DTX DTX SECHRIST INDUSTRIES, INC 3500CP-G

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Death