BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XN-20

    MDR report key: 7647958 · Received June 28, 2018

    Report

    Report Number
    1000515253-2018-00009
    Event Type
    Malfunction
    Date Received
    June 28, 2018
    Date of Event
    May 30, 2018
    Report Date
    July 31, 2018
    Manufacturer
    SYSMEX CORPORATION
    Product Code
    GKZ
    UDI-DI
    04987562424221
    PMA / PMN Number
    K112605
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION HAS REVEALED THAT THE TRANSLATION OF THE FIELD CORRECTIVE ACTION (FCA) FOR FIELD SERVICE ENGINEERS (FSES) IN CHINA WAS INCOMPLETE, IN THAT IT DID NOT INCLUDE INSTRUCTIONS FOR PLACEMENT AND SECURING OF WATERPROOF PROTECTIVE SHEETS DURING THE CORRECTION PROCESS. THE FCA HAS BEEN CORRECTED AND RE-DISTRIBUTED TO ALL FSES IN CHINA. ADDITIONALLY, A VERIFICATION PROCESS HAS BEEN INSTITUTED BY SYSMEX CORPORATION JAPAN (S-CORP), TO ENSURE TRANSLATIONS ARE ACCURATE AND REFLECT THE MANUFACTURER'S INSTRUCTIONS.

    Additional Manufacturer Narrative · 1

    SYSMEX CORPORATION (B)(4) (S-CORP) INITIATED A FIELD CORRECTIVE ACTION (FCA) AFTER A SIMILAR EVENT OCCURRED IN 2016. THIS WAS DONE AS A COUNTERMEASURE TO PREVENT POTENTIAL ELECTRICAL DAMAGE DUE TO FLUID LEAKAGE. THE FCA INCLUDES REARRANGEMENT OF WIRING CORDS AND PLACEMENT OF WATERPROOF SHEETS OVER VALVE ASSEMBLIES. SYSMEX (B)(4) (SCH) PERFORMED THE FCA AT THIS FACILITY. AFTER INVESTIGATION BY S-CORP, IT WAS CONFIRMED THAT THE FOLLOWING WITHIN THE FCA WAS PERFORMED INCORRECTLY: PROTECTIVE SHEETS WERE NOT APPLIED TO ALL AREAS, PROTECTIVE SHEETS WERE NOT SECURED IN POSITION, THE WIRING WITHIN THE XN-20 WAS NOT REROUTED ACCORDING TO INSTRUCTION. INVESTIGATION REGARDING ROOT CAUSE DETERMINATION CONTINUES.

    Description of Event or Problem · 1

    A USER IN (B)(6) REPORTED A BURNING ODOR COMING FROM INSIDE THE ANALYZER. A FIELD SERVICE ENGINEER (FSE) ARRIVED ON-SITE AND DISCOVERED LEAKAGE FROM A BROKEN NIPPLE ON MASTER VALVE 84 WHICH IS LOCATED IN THE VALVE ASSEMBLY 22. THE TUBING CONNECTED TO THE BROKEN NIPPLE CAUSED LEAKING ONTO VALVE ASSEMBLY 19. THE FLUID FROM THE LEAKAGE HAD DRIED OVER TIME, LEAVING SALT RESIDUE IN THE AREA. ON VALVE ASSEMBLY 19, THE FSE ALSO DISCOVERED THE PROTECTIVE PLASTIC SHEET AND WIRES WERE MELTED AND CHARRED. NO HARM OR INJURY TO OPERATOR WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    488870 XN-20 AUTOMATED HEMATOLOGY ANALYZER GKZ SYSMEX CORPORATION XN-20 04987562424221

    Patients

    Seq Age Sex Outcome Treatment
    1