BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIA-2000

    MDR report key: 7162784 · Received January 3, 2018

    Report

    Report Number
    8031673-2017-00234
    Event Type
    Malfunction
    Date Received
    January 3, 2018
    Date of Event
    December 4, 2017
    Report Date
    January 3, 2018
    Manufacturer
    TOSOH CORPORATION
    Product Code
    KHO
    PMA / PMN Number
    K971103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    TOSOH BIOSCIENCE, INC. IS SUBMITTING ON BEHALF OF THE FOREIGN MANUFACTURER, TOSOH CORPORATION, PER EXEMPTION NUMBER E2017013. DEVICE EVALUATION BY MANUFACTURER: ON (B)(6) 2017, FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER'S FACILITY TO ADDRESS THE ISSUE. FSE IDENTIFIED LOOSE FITTING ON A 3-WAY SOLENOID VALVE (SV 293) TO BE THE CAUSE OF THE ERRORS. FSE TIGHTEN THE FITTING, CHECKED FITTING ON ALL VALVE, AND PERFORMED DAILY MAINTENANCE. THE CUSTOMER RAN QUALITY CONTROLS AND RESULTS WERE IN ACCEPTABLE RANGE. THE INSTRUMENT WAS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER ACTION REQUIRED BY FSE. A 13-MONTH COMPLAINT HISTORY REVIEW AND SERVICE HISTORY REVIEW FOR SERIAL NUMBER (B)(4) FOR (B)(6) 2016 THROUGH (B)(6) 2017 FOR SIMILAR COMPLAINTS WERE PERFORMED. THERE WERE NO OTHER SIMILAR COMPLAINTS IDENTIFIED DURING THE SEARCHED PERIOD. THE AIA-2000 OPERATOR'S MANUAL UNDER CHAPTER 6: SYSTEM OPERATION AND APPENDIX 4: ERROR MESSAGES OUTLINED THE ERRORS UNDER MAINTENANCE ROUTINE (1) PRIMING THE SUBSTRATE LINE PRIME THE SUBSTRATE LINE WITH THE SUBSTRATE. (2) FLUSH THE WASH SOLUTION. FLUSH OUT ANY WASH SOLUTION REMAINING IN THE WASH LINES. THE FOLLOWING ERROR MESSAGES APPEAR IF THE WASH SOLUTIONS ARE NOT PROPERLY FLUSHED. "(B)(4): B/F PROBE 1 FLUSH FAILURE" APPEARS WHEN B/F PROBE 1 FLUSH FAILS. "(B)(4): B/F PROBE 2 FLUSH FAILURE" APPEARS WHEN B/F PROBE 2 FLUSH FAILS. "(B)(4): B/F PROBE 3 FLUSH FAILURE" APPEARS WHEN B/F PROBE 3 FLUSH FAILS. "(B)(4): B/F PROBE 4 FLUSH FAILURE" APPEARS WHEN B/F PROBE 4 FLUSH FAILS. THESE MESSAGES INDICATE THAT AIR WAS NOT COMPLETELY FLUSHED FROM THE WASH SOLUTION LINES. IF ERRORS OCCUR, PRESS THE B/F PROBE KEY ON THE AIA-2000 SHEET KEY, OPEN THE COVER AND CHECK B/F UNIT FOR POSSIBLE CAUSES OF THE MALFUNCTION. AFTER THIS, CLICK PRIME WASH SOLUTION BUTTON ON THE OPERATION PANEL (TOOLBAR) TO REPEAT THE FLUSH PROCEDURE UNTIL THE LINES ARE FULL AND THE ERRORS STOP. CONTACT A TOSOH SERVICE CENTER OR LOCAL REPRESENTATIVES IF ERROR MESSAGES STILL APPEAR AFTER FLUSHING 5 TIMES OR MORE. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT IS DUE TO LOOSE FITTING ON SV 293 3-WAY WASH VALVE.

    Description of Event or Problem · 0

    ON (B)(6) 2017 A CUSTOMER REPORTED GETTING B/F (BOUND /FREE) WASH PROBE PURGE ERRORS, INCLUDING ERROR (B)(4) B/F PROBE 1 PURGE FAILURE, ERROR (B)(4) B/F PROBE 2 PURGE FAILURE, ERROR (B)(4) B/F PROBE 3 PURGE FAILURE, AND ERROR (B)(4) B/F PROBE 4 PURGE FAILURE ON THE AIA-2000. THE CUSTOMER WAS UNABLE TO RUN PATIENT SAMPLES ON FOLLICLE STIMULATING HORMONE (FSH). FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ADDRESS THE REPORTED EVENT, WHICH RESULTED IN DELAY IN REPORTING OF PATIENT RESULTS FOR (FSH). THERE IS NO INDICATION OF ANY PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DELAY IN REPORTING OF PATIENT RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5583 AIA-2000 AIA-2000 KHO TOSOH CORPORATION AIA-2000

    Patients

    Seq Age Sex Outcome Treatment
    1