BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SECHRIST AIR/OXYGEN GAS BLENDER

    MDR report key: 12682850 · Received October 22, 2021

    Report

    Report Number
    2020676-2021-00029
    Event Type
    Injury
    Date Received
    October 22, 2021
    Date of Event
    September 7, 2021
    Report Date
    October 21, 2021
    Manufacturer
    SECHRIST INDUSTRIES, INC
    Product Code
    DTX
    PMA / PMN Number
    K023745
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER INITIALLY REPORTED THAT THE ALARM DOES NOT WORK AS IT SHOULD. AFTER THIS ISSUE WAS REPORTED, A 3RD PARTY SERVICE TECHNICIAN WAS SENT TO THE HOSPITAL TO SERVICE THE UNIT. THE SERVICE REPAIR FORM INDICATED THE ALARM MODULE WAS REPLACED, THEN THE UNIT WAS TESTED AND RETURNED TO THE HOSPITAL IN WORKING CONDITION. THE DEFECTIVE ALARM MODULE WAS DISPOSED. IN ADDITION, THE THIRD-PARTY SERVICE PROVIDER, REPORTED THE DEVICE WAS PREVIOUSLY SERVICED AND OVERHAULED IN DECEMBER 2020. SECHRIST MIXER USER'S MANUAL INDICATES THAT PRODUCT MUST BE TESTED BEFORE CLINICALLY USED. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOUND NO NON-CONFORMANCE THAT COULD CAUSE OR CONTRIBUTE TO THE REPORTED ISSUE. BASED ON THE AGE OF THE DEVICE (MFG DATE FEB. 2010), IT IS UNLIKELY THAT A MANUFACTURING NON-CONFORMANCE CONTRIBUTED TO THE REPORTED ISSUE. 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 · 0

    CUSTOMER REPORTED THE PATIENT'S O2 SATURATION IS MUCH BELOW 90% WHEN TREATED WITH AN ECMO, IN WHICH AN O2 / AIR GAS MIXER FROM SECHRIST WAS IN USE. AFTER THE ERROR ANALYSIS, IT WAS DETERMINED THAT THE O2 SUPPLY WAS INTERRUPTED AND THE GAS MIXER GAVE NO ALARM. CUSTOMER INFORMED SECHRIST, THERE WAS NO OBVIOUS HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1582993 SECHRIST AIR/OXYGEN GAS BLENDER GAS CONTROL UNIT, CARDIOPULMONARY BYPASS DTX SECHRIST INDUSTRIES, INC 3500CP-G

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention