BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SECHRIST GAS BLENDER MODEL 3500

    MDR report key: 3871271 · Received April 15, 2014

    Report

    Report Number
    2020676-2014-00016
    Event Type
    Malfunction
    Date Received
    April 15, 2014
    Date of Event
    March 14, 2014
    Report Date
    April 15, 2014
    Manufacturer
    SECHRIST INDUSTRIES
    Product Code
    BZR
    PMA / PMN Number
    K802226
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL OF THE DEVICE WAS COMPLETED BY THE MFR. VISUAL INSPECTION FOUND THAT FITTINGS WERE MISSING FROM THE WATER TRAP AND OXYGEN CONNECTOR, AN EXTRA FLOW METER WAS ATTACHED TO THE SIDE OF THE DEVICE AND ONE OF THE SCREWS IS MISSING FROM THE ALARM BLOCK. TO TEST THE DEVICE A TEST FITTING WAS PLACED ON THE OXYGEN CONNECTOR. TESTING OF THE MIXER FOUND THAT THE PROPORTIONING VALVE WOULD ONLY READ 21.2% OXYGEN AND THERE WAS NO FLOW OUTPUT. NO FURTHER TESTING COULD BE COMPLETED. UPON TURNING OFF THE GAS FLOW, THE 100-1000 ML/MIN FLOAT BALL WOULD STICK TO THE TOP OF THE FLOW METER AND THEN DROP DOWN. AS FURTHER TESTING COULD NOT BE COMPLETED, THE MIXER WAS FURTHER INSPECTED. THE LOCK NUT ON THE PROPORTIONING VALVE AND THE CHECK VALVE ON THE RETAINER WERE FOUND TO BE LOOSE. FURTHER EXAMINATION OF THE PROPORTIONING VALVE FOUND THAT ONE OF THE O-RINGS APPEARED TO BE CUT. IN ADDITION, THE FIO2 ADJUSTER NEEDLE WAS TURNED OUT TOO FAR. PER THE CUSTOMER, THE MIXER HAD BEEN OVERHAULED IN 02/2014 BY A THIRD PARTY. THE THIRD PARTY IS NOT RECOGNIZED BY THE MFR AS HAVING BEEN TRAINED TO COMPLETE MAINTENANCE AND/OR REPAIRS ON THE MFR'S DEVICES. THE ROOT CAUSE FOR THE FAILURE OF THE MIXER IS TAMPERING AND/OR ATTEMPTED MAINTENANCE. THE DEVICE WAS NOT CALIBRATED PROPERLY DURING THE OVERHAUL IN 02/2014. THE ROOT CAUSE FOR THE FAILURE OF THE FLOAT BALL IN THE FLOW METER IS AGE AND/OR WEAR AND TEAR. THE FLOW METER IS THE ORIGINAL FLOW METER FROM TIME OF THE MFR AND IS 26 YEARS OLD.

    Description of Event or Problem · 1

    THE CUSTOMER ORIGINALLY REPORTED THAT THE MIXER FAILED DURING CLINICAL USE. THERE WAS "NO FLOW" COMING FROM THE DEVICE. FURTHER INFO RECEIVED FROM THE CUSTOMER PROVIDED THE FOLLOWING DETAILS: THE CUSTOMER REPORTED THAT DURING A CARDIOPULMONARY BYPASS THE PT RECEIVED LOW OXYGENATION. THERE EVENT OCCURRED IMMEDIATELY WHEN THE DEVICE WENT ON CARDIOPULMONARY BYPASS. THE MIXER WAS IMMEDIATELY REPLACED WITH ANOTHER UNIT. THERE WAS NO DELAY IN THE PROCEDURE AS THE EXCHANGE TOOK PLACE DURING THE SURGERY. THE PT HAS SINCE BEEN RELEASED FROM THE HOSPITAL AND IS REPORTED AS "DOING FINE". THE MIXER DID NOT ALARM. A DOWNSTREAM ALARM AND OXYGEN ANALYZER WERE NOT CONNECTED TO THE DEVICE SET-UP. THE MIXER WAS SET AT 4 LITERS PER MINUTE AT 100% FIO2. A PERFORMANCE VERIFICATION WAS COMPLETED PRIOR TO THE DEVICE BEING PLACED INTO CLINICAL USE. NO ISSUES WERE FOUND DURING THE PERFORMANCE VERIFICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230637 SECHRIST GAS BLENDER MODEL 3500 MIXER, GENERAL BZR SECHRIST INDUSTRIES 3500T

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention