BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIA-2000

    MDR report key: 7368311 · Received March 23, 2018

    Report

    Report Number
    8031673-2018-00245
    Event Type
    Malfunction
    Date Received
    March 23, 2018
    Date of Event
    March 2, 2018
    Report Date
    October 2, 2018
    Manufacturer
    TOSOH CORPORATION
    Product Code
    KHO
    PMA / PMN Number
    K971103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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) 2018, A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER'S FACILITY TO ADDRESS THE REPORTED EVENT. FSE CONFIRMED THE B/F (BOUND/FREE) PROBE 3 PURGE ISSUE WITH EACH PRIME CYCLE. FSE FOUND PARTIAL BLOCKAGE INSIDE THE B/F 3 WASH SOLENOID (B)(4) IN ADDITION TO DIRTY/RUSTY WASH SYRINGES. FSE ORDERED THE PART TO BE DELIVERED THE NEXT DAY TO THE FACILITY. ON (B)(6) 2018, FSE RETURNED TO THE FACILITY AND REPLACED THE DELIVERED 3-WAY-WASHER SOLENOID VALVE AND THE WASH SYRINGES. FSE THEN PRIMED THE INSTRUMENT SEVERAL TIMES AND RAN QUALITY CONTROLS (QC). ALL RESULTS PASSED WITHIN ACCEPTABLE RANGE. THE AIA-2000 INSTRUMENT WAS PERFORMING WITHIN SPECIFICATIONS AND THE ERROR 2241 MESSAGE CLEARED. NO FURTHER ACTION REQUIRED BY FSE. A 13-MONTH COMPLAINT HISTORY REVIEW AND SERVICE HISTORY REVIEW FOR (B)(4) FOR (B)(6) 2017 THROUGH AWARE DATE (B)(6) 2018 FOR SIMILAR COMPLAINTS WERE PERFORMED. THERE WAS ONE OTHER SIMILAR COMPLAINT IDENTIFIED DURING THE SEARCHED PERIOD: TICKET (B)(4) RECEIVED (B)(6) 2017. 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 MESSAGE APPEARS IF THE WASH SOLUTIONS ARE NOT PROPERLY FLUSHED. "2241: B/F PROBE 3 FLUSH FAILURE" APPEARS WHEN B/F PROBE 3 FLUSH FAILS. THE MESSAGE INDICATES 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. ERROR 2241 IS B/F (BOUND/FREE) PROBE 3 PURGE FAILURES. THE MESSAGE IS GENERATED WHEN THE OVERFLOW SENSOR FAILED TO DETECT LIQUID EVEN AFTER THE WASHER WAS PURGED. THE SOLUTION FOR THE CUSTOMER IS AIR MAY BE TRAPPED IN THE WASHER TUBING. PURGE ANY REMAINING AIR BY PERFORMING THE PRIMING OPERATION AND CHECK FOR THE PRESENCE OF AIR IN THE WASHER TUBING. IF RETRY FAILS, CONTACT TOSOH SERVICE CENTER OR LOCAL REPRESENTATIVES. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT IS DUE TO BLOCKAGE AT THE SOLENOID VALVE AND DIRTY/RUSTY WASH SYRINGES.

    Additional Manufacturer Narrative · 0

    TOSOH BIOSCIENCE, INC. IS SUBMITTING ON BEHALF OF THE FOREIGN MANUFACTURER, TOSOH CORPORATION, PER EXEMPTION NUMBER E2017013. SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE IMPORTER OR MANUFACTURER'S PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 0

    ON (B)(6) 2018, A CUSTOMER REPORTED GETTING ERROR 2241 B/F (BOUND /FREE) 3 PURGE WHILE RUNNING PATIENT SAMPLES ON THE AIA-2000 INSTRUMENT. THE CUSTOMER WAS UNABLE TO RUN PATIENT SAMPLES ON INTACT PARATHYROID HORMONE (IPTH). ON (B)(6) 2018, FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ADDRESS THE REPORTED EVENT, WHICH RESULTED IN DELAY IN REPORTING OF PATIENT RESULTS FOR IPTH. 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
    208248 AIA-2000 AIA-2000 KHO TOSOH CORPORATION AIA-2000

    Patients

    Seq Age Sex Outcome Treatment
    1