BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIA-2000

    MDR report key: 7801231 · Received August 21, 2018

    Report

    Report Number
    8031673-2018-00792
    Event Type
    Malfunction
    Date Received
    August 21, 2018
    Date of Event
    August 9, 2018
    Report Date
    November 23, 2018
    Manufacturer
    TOSOH CORPORATION
    Product Code
    KHO
    PMA / PMN Number
    K971103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    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: FIELD SERVICE ENGINEERING (FSE) VISITED THE CUSTOMER TO ADDRESS THE REPORTED EVENT. DURING THE VISIT, FSE CONFIRMED SEVERAL ENTRIES OF BF PROBE 4 OVERFLOW SENSOR FAILURES IN THE ERROR LOG. FSE CHECKED CONTINUITY OF PINK AND BLUE ELECTRICAL WIRES AT THE PROBE AND OBSERVED NO ANOMALIES. FSE RAN THE BF PRIME WASH AND OBSERVED THE ERROR. FSE RE-RAN THE BF PRIME WASH AND CHECKED FOR THE FLOW AND EVACUATION OF THE WASH. THERE WAS NO FLOW OF THE WASH OBSERVED. FSE CHECKED THE FITTINGS OF THE WASH TUBING FOR THE TIGHTNESS AND FOUND THAT THE FITTINGS WERE TIGHT. FSE CHECKED THE WASH VALVE WHILE RUNNING THE BF PRIME WASH AND OBSERVED BUBBLES IN THE LINE. FSE THEN REPLACED THE BF PROBE 4 WASH VALVE. FSE RAN SEVERAL BF PRIME WASHES WITHOUT ANY ERRORS. THE INSTRUMENT WAS OPERATING AS EXPECTED. THERE WAS NO FURTHER ACTION REQUIRED BY FSE. THE INSTRUMENT WAS INSTALLED ON (B)(6) 2017. A COMPLAINT HISTORY REVIEW AND SERVICE HISTORY REVIEW FOR SIMILAR COMPLAINTS WAS PERFORMED FOR SERIAL NUMBER (B)(4) FROM (B)(6) 2017 THROUGH AWARE DATE (B)(6) 2018. THERE WERE NO SIMILAR COMPLAINTS FOUND. THE AIA-2000 OPERATOR'S MANUAL UNDER APPENDIX 4 - ERROR MESSAGES STATES THE FOLLOWING: THE 2242 B/F PROBE 4 PURGE FAILURE- CAUSE : THE OVERFLOW SENSOR FAILED TO DETECT LIQUID EVEN AFTER THE WASHER WAS PURGED. SOLUTION : 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. SECTION 6.2.2 MAINTENANCE ROUTINE STATES: PRIMING THE SUBSTRATE LINE; PRIME THE SUBSTRATE LINE WITH THE SUBSTRATE. FLUSH THE WASH SOLUTION. FLUSH OUT ANY WASH SOLUTION REMAINING IN THE WASH LINES. THE FOLLOWING ERROR MESSAGES APPEAR IF THE WASH SOLUTION ARE NOT PROPERLY FLUSHED. THE "2239: B/F PROBE 1 FLUSH FAILURE" APPEARS WHEN B/F PROBE 1 FLUSH FAILS. THE"2240: B/F PROBE 2 FLUSH FAILURE" APPEARS WHEN B/F PROBE 2 FLUSH FAILS. THE "2241: B/F PROBE 3 FLUSH FAILURE" APPEARS WHEN B/F PROBE 3 FLUSH FAILS. THE "2242: 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 2242 B/F PROBE 4 PURGE FAILURE ERROR MESSAGES WAS DUE TO A BAD SOLENOID VALVE FOR THE BF PROBE 4.

    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. ADDITIONAL INFORMATION: A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS CONDUCTED FOR SERIAL NUMBER (B)(4), WHICH CONFIRMED THAT THERE WERE NO NONCONFORMANCES, FAILURES, DISCREPANCIES, OR MISSED STEPS DURING THE MANUFACTURING PROCESS THAT COULD BE RELATED TO THE REPORTED EVENT.

    Description of Event or Problem · 0

    A CUSTOMER REPORTED ERROR 2242 B/F PROBE 4 PURGE FAILURE WITH THE AIA-2000 INSTRUMENT. THE CUSTOMER TRIED TO REPLACE THE WASH, TIPS, AND CERAMIC FILTER. THE CUSTOMER PRIMED THE INSTRUMENT SEVERAL TIMES BUT THE ERROR DID NOT CLEAR. THE TUBING TO THE WASH PROBE WAS CONNECTED. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ADDRESS THE REPORTED EVENT, WHICH RESULTED IN DELAYED REPORTING OF PARATHYROID HORMONE (IPTH), FOLLICLE-STIMULATING HORMONE (FSH), LUTEINIZING HORMONE (LHII), AND PROLACTIN (PRL) PATIENT RESULTS. THERE WAS NO INDICATION OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DELAY IN REPORTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    641678 AIA-2000 AIA-2000 KHO TOSOH CORPORATION AIA-2000

    Patients

    Seq Age Sex Outcome Treatment
    1