BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APTIO AUTOMATION

    MDR report key: 8173266 · Received December 18, 2018

    Report

    Report Number
    3010825766-2018-00001
    Event Type
    Malfunction
    Date Received
    December 18, 2018
    Report Date
    April 2, 2019
    Manufacturer
    INPECO SA
    Product Code
    JQP
    UDI-DI
    07640172342008
    PMA / PMN Number
    K121012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    UPON INPECO REQUEST, THE PISTONS SUPPLIER PROVIDED A REPORT WITH THE PROBLEM ANALYSIS AND ROOT CAUSE, THAT WAS THEN REVIEWED AND ACKNOWLEDGED BY INPECO. SOME BATCHES OF THE PISTONS HAVE BEEN TREATED WITH A GREASE NOT FORESEEN BY DESIGN. THE USE OF A WRONG GREASE WAS DUE TO AN HUMAN ERROR (SUPPLIER PERSONNEL ERROR) DURING MANUFACTURING PROCESS. THE PISTONS WITH THE WRONG GREASE, DEPENDING OF GREASE QUANTITY AND WORKING CONDITION, HAVE A HIGHER PROBABILITY TO BEHAVE CLOSER TO THE ACCELERATION BOUNDARY, AND MAY LEAD TO AN ACTIVATION OF THE GATE NOT SYNCHRONIZED WITH THE SAMPLE CARRIER PASSAGE. THE PISTONS SUPPLIER INFORMED INPECO THAT THE CORRECT PRODUCTION PROCESS HAS BEEN RESTORED: THE WRONG GREASE HAS BEEN REMOVED ON EVERY WORK PLACE THAT PRODUCE THE PISTONS, AND WORKING INSTRUCTIONS HAS BEEN UPDATED TO PREVENT RE-OCCURRENCE OF THE PROBLEM. THE PISTONS TREATED WITH THE NON-CONFORMING GREASE HAVE NOT BEEN EVALUATED AS DEFECTIVE, SINCE THEY HAVE JUST AN HIGHER PROBABILITY TO BEHAVE CLOSER TO THE ACCELERATION BOUNDARY: THE GATES EQUIPPED WITH THESE PISTONS WORK ACCORDING TO DESIGN SPECIFICATIONS. FOR THIS REASON, IT IS NOT REQUIRED THE REPLACEMENT ON THE FIELD OF THE GATES WITH THE NON-CONFORMING GREASE, AND INPECO EVALUATED THAT A FIELD SAFETY CORRECTIVE ACTION IS NOT NEEDED. NO INJURY TO PATIENT WAS REPORTED FROM THE CUSTOMER. NO OTHER SIMILAR EVENT THAT LED TO SAMPLE SPILLAGE WAS REPORTED FROM THE FIELD. NO FURTHER INVESTIGATION IS REQUIRED.

    Additional Manufacturer Narrative · 1

    DUE TO A NO LONGER VALID OCCUPATION CODE (INITIAL IMPORTER OCCUPATION) THE EMDR WAS NOT CORRECTLY SAVED IN THE CDRH'S ADVERSE EVENT DATABASE. ALL THE OTHER DATA ARE CONFIRMED.

    Description of Event or Problem · 1

    THE PRODUCT DISTRIBUTOR HAS NOTIFIED INPECO THAT STOP GATES BECOME "STUCK" AND TRACK JAMS AND SPLASHING OCCURS. THE SAMPLE SPLASH FROM TUBES MAY CAUSE CROSS CONTAMINATION. THE COVERS AVOID THAT THE OPERATORS CAN COME IN CONTACT WITH THE SPILLED SAMPLE. NOTE: THE STOP GATE IS THE GATE ON THE AUTOMATION MAIN TRACK WHICH IS ACTIVATED TO TEMPORARY STOP THE SAMPLE CARRIERS ROUTING TO ALLOW THE SAMPLE CARRIER RETURN FROM THE MODULE/INTERFACE MODULE BUFFER TO THE MAIN TRACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1012572 APTIO AUTOMATION LABORATORY AUTOMATION SYSTEM JQP INPECO SA AP2 07640172342008

    Patients

    Seq Age Sex Outcome Treatment
    1 Other