BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIA-360

    MDR report key: 9246206 · Received October 28, 2019

    Report

    Report Number
    8031673-2019-00426
    Event Type
    Malfunction
    Date Received
    October 28, 2019
    Date of Event
    October 7, 2019
    Report Date
    December 18, 2019
    Manufacturer
    TOSOH CORPORATION
    Product Code
    KHO
    PMA / PMN Number
    K971103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE DILUENT PUMP AND WASH PUMP (QTY, 2) (PART # 0021124) WAS RETURNED TO TOSOH INSTRUMENT SERVICE CENTER FOR INVESTIGATION. FUNCTIONAL TESTING COULD NOT CONFIRM THE REPORTED ISSUE WAS DUE TO FAILURE OF THE DILUENT PUMP OR WASH PUMP AS THE ERROR COULD NOT BE DUPLICATED. THE 2-WAY SOLENOID AND 3-WAY SOLENOID VALVE (PART # 0021105/0021105) WAS RETURNED TO TOSOH INSTRUMENT SERVICE CENTER FOR INVESTIGATION. FUNCTIONAL TESTING COULD NOT CONFIRM THE REPORTED ISSUE WAS DUE TO FAILURE OF THE SOLENOID VALVES AS THE ERROR COULD NOT BE DUPLICATED. THE LEVEL SENSOR LEADS (PART # 0021138) WAS RETURNED TO TOSOH INSTRUMENT SERVICE CENTER FOR INVESTIGATION. FUNCTIONAL TESTING COULD NOT CONFIRM THE REPORTED ISSUE WAS DUE TO FAILURE OF LEVEL SENSOR LEADS AS THE ERROR COULD NOT BE DUPLICATED. THE WASTE PUMP (PART# 0021567) WAS RETURNED TO TOSOH INSTRUMENT SERVICE CENTER FOR INVESTIGATION. FUNCTIONAL TESTING CONFIRMED THE REPORTED ISSUE WAS DUE TO FAILURE OF THE WASTE PUMP; THE PART EXHIBITED A PROBLEM OF WORKING INTERMITTENTLY. THE PROBABLE CAUSE OF THE REPORTED EVENT WAS DUE TO FAILURE OF THE WASTE PUMP.

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WAS AT CUSTOMER SITE TO ADDRESS THE REPORTED EVENT. THE FSE WAS ABLE TO CONFIRM THE ERROR BY REVIEWING THE ERROR LOG AND REPRODUCED THE ERROR WHILE TRYING TO PRIME THE B/F WASH. THE FSE REPLACED THE RELATED PARTS. THE INSTRUMENT THEN OPERATED AS EXPECTED AND RETURNED TO USE. THE FSE ALSO UPGRADED THE SOFTWARE TO VERSION 1.38U. NO FURTHER ACTION REQUIRED BY FIELD SERVICE. THE AIA-360 INSTRUMENT IS FUNCTIONING AS EXPECTED. A 13-MONTH COMPLAINT HISTORY REVIEW AND SERVICE HISTORY REVIEW FOR SIMILAR COMPLAINTS WAS PERFORMED FOR THE SERIAL NUMBER (B)(4) FROM 07SEPTEMBER2018 THROUGH AWARE DATE 07OCTOBER2019. THERE WERE NO OTHER SIMILAR COMPLAINTS IDENTIFIED DURING THE REVIEW PERIOD. THE AIA-360 OPERATOR'S MANUAL UNDER SECTION 7-1: LIST OF ERROR MESSAGES STATES THE FOLLOWING: 2015 BF PROBE PURGE FAILURE. DESCRIPTION: PURGING BY THE BF PROBE IS ABNORMAL. TROUBLESHOOTING: CLEAN UP THE WASH PROBE TIP OR REPLACE IT. CONTACT THE SERVICE DEPARTMENT. THE PROBABLE CAUSE OF THE REPORTED EVENT IS PENDING INVESTIGATION COMPLETION.

    Description of Event or Problem · 1

    AA CUSTOMER REPORTED GETTING ERROR MESSAGE 2015 BF PROBE PURGE FAILURE ON THE AIA-360 INSTRUMENT. THE CUSTOMER STATED THAT THE WASH PROBE TIPS HAD ALREADY BEEN CLEANED. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ADDRESS THE REPORTED EVENT, WHICH RESULTED IN DELAYED REPORTING OF BETA HUMAN CHORIONIC GONADOTROPIN (BHCG), ESTRADIOL (E2), AND PROGESTERONE (PROG II) 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
    1040500 AIA-360 AIA-360 KHO TOSOH CORPORATION AIA-360

    Patients

    Seq Age Sex Outcome Treatment
    1