BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SECHRIST AIR/OXYGEN GAS BLENDER MODEL 3500CP-G

    MDR report key: 15196143 · Received August 9, 2022

    Report

    Report Number
    2020676-2022-00022
    Event Type
    Malfunction
    Date Received
    August 9, 2022
    Date of Event
    July 12, 2022
    Report Date
    August 9, 2022
    Manufacturer
    SECHRIST INDUSTRIES, INC
    Product Code
    DTX
    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

    THE SECHRIST EQUIPMENT WAS FUNCTIONALLY CHECKED, BY SERVICE TECHNICIAN, WITHOUT ANY DEVIATION FROM SPECIFICATIONS IDENTIFIED. NO OUT OF RANGE VALUES FOR FIO2 DELIVERY WERE MEASURED AND NO ALARM MONITORING SYSTEM ISSUE WAS REPRODUCED. UNIT WAS FOUND TO BE WORKING PROPERLY. BASED ON SERVICE RECORD RESULTS, PROVIDED BY THE CUSTOMER, THE UNIT WAS SERVICED AND RELEASED FOR PATIENT USE. THEREFORE, NO CORRECTIVE OR PREVENTIVE ACTIONS ARE NECESSARY. AS INDICATED IN THE USER'S MANUAL, AS PART OF PERFORMANCE VERIFICATION, THE USER SHALL "PRIOR TO EACH CLINICAL USAGE, THE USER SHOULD PERFORM AN ALARM TEST AND ANALYZE THE FULL FIO2 RANGE. WITH AN ACCURATELY CALIBRATED OXYGEN ANALYZER, THE USER SHOULD ANALYZE THE FIO2 AT THE FOLLOWING SETTINGS; 21%, 40%, 60%, 80%, AND 100%. ADDITIONALLY, THE USER SHOULD BRIEFLY DISCONNECT ONE SUPPLY GAS TO ASSURE THAT THE BYPASS/ALARM SYSTEM IS FUNCTIONING. WITH A SINGLE SUPPLY GAS DISCONNECTED, THE AUDIBLE ALARM SHOULD SOUND AND THE ANALYZED FIO2 SHOULD INDICATE THE FIO2 OF THE SINGLE SUPPLY GAS; I.E. 21% IF THE OXYGEN WAS DISCONNECTED AND 100% IF THE AIR SUPPLY WAS DISCONNECTED." FURTHERMORE, THE SECHRIST BLENDER MUST BE OVERHAULED EVERY 2 YEARS. 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 POOR OXYGENATION OF THE EQUIPMENT PN 96-490-042, SN (B)(4). THE ISSUE WAS DISCOVERED DURING CLINICAL USE AS NO MARKED COLOR DIFFERENCE BETWEEN ARTERIAL AND VENOUS BLOOD WAS NOTICED AT THE BEGINNING OF SURGERY. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1606699 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