BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIA-360

    MDR report key: 7635382 · Received June 25, 2018

    Report

    Report Number
    8031673-2018-00466
    Event Type
    Malfunction
    Date Received
    June 25, 2018
    Date of Event
    May 3, 2018
    Report Date
    December 5, 2023
    Manufacturer
    TOSOH BIOSCIENCE, INC.
    Product Code
    KHO
    PMA / PMN Number
    K971103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PLEASE NOTE THAT THIS MDR MFR REPORT #: WAS PREVIOUSLY SUBMITTED TO THE FDA UNDER 3005529799-2018-00466 ON 18MAY2018; IT WAS RENAMED & RESUBMITTED PER REQUEST BY THE FDA MDR DATA SYSTEMS TEAM REPRESENTATIVE. 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. FSE ARRIVED AT THE SITE TO ADDRESS THE REPORTED EVENT. INSPECTION OF THE DEVICE DID NOT REVEAL ANY LEAKS. FSE REPLACED THE DILUENT WASH PUMP, AND THEN SUCCESSFULLY PRIMED IT SEVERAL TIMES. NEXT, HE RAN THE BF PRIME DIAGNOSTIC WITH THE WASH PROBE IN A SAMPLE CUP. IT DISPENSED FLUID CONSISTENTLY AND ASPIRATED PROPERLY. FSE WAS SUBSEQUENTLY ABLE TO RUN QUALITY CONTROL (QC) WITHOUT ISSUE. THE DILUENT WASH PUMP IS BEING RETURNED TO THE MANUFACTURER FOR EVALUATION. NO FURTHER ISSUES WERE NOTED. NO FURTHER ACTION WAS REQUIRED BY FIELD SERVICE. A 13 MONTH COMPLAINT HISTORY REVIEW AND SERVICE HISTORY REVIEW FOR SIMILAR COMPLAINTS WAS PERFORMED FOR THE SERIAL NUMBER (B)(6) FROM 03APR2017 THROUGH AWARE DATE 03MAY2018. THERE WERE TWO SIMILAR COMPLAINTS IDENTIFIED DURING THE SEARCH PERIOD. 2015 BF PROBE PURGE FAILURE. THE AIA-360 SERVICE MANUAL REVISION 1, UNDER THE APPENDIX -CONTROL-RELATED ERRORS WAS REVIEWED. THE AIA-360 SERVICE MANUAL INDICATES THAT THE 2015 BF PROBE PURGE FAILURE ERROR MESSAGE IS GENERATED WHEN PURGING OF THE BF PROBE IS ABNORMAL. THE OPERATOR IS INSTRUCTED TO CLEAN AND/OR REPLACE THE WASH PROBE TIP AND CONTACT TOSOH CUSTOMER SERVICE. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT WAS DUE TO FAILURE OF THE DILUENT WASH PUMP.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CUSTOMER RECEIVED "ERROR 2015 BF PROBE PURGE FAILURE" WITH THEIR AIA-360 ANALYZER. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ADDRESS THE REPORTED EVENT, WHICH RESULTED IN DELAY IN REPORTING OF PATIENT RESULTS FOR CARDIAC TROPONIN-I 2ND GENERATION (CTNL2). THERE WAS 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
    478889 AIA-360 AIA-360 KHO TOSOH BIOSCIENCE, INC. AIA-360

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown