BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSMEX TS-10

    MDR report key: 9542013 · Received January 2, 2020

    Report

    Report Number
    1000515253-2020-00002
    Event Type
    Malfunction
    Date Received
    January 2, 2020
    Date of Event
    March 18, 2019
    Report Date
    March 4, 2020
    Manufacturer
    SYSMEX RA CO. LTD.
    Product Code
    LXG
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SYSMEX CORPORATION JAPAN (S-CORP) COMPLETED THE INVESTIGATION. THE INVESTIGATION DETERMINED INSUFFICIENT TIGHTENING OF THE FUSE HOLDER CAP DURING THE SUPPLIER ASSEMBLY PROCESS CAUSED THE EVENT. INSUFFICIENT CONTACT BETWEEN THE FUSE HOLDER CAP AND THE FUSE LED TO HEAT GENERATION CAUSING THE FUSE HOLDER TO BURN. S-CORP WAS ABLE TO REPRODUCE THE ISSUE. THE FUSE HOLDER IS MADE OF FLAME RESISTANT MATERIAL. FLAME RESISTANT MATERIALS ARE DESIGNED TO PREVENT COMBUSTION; HOWEVER, STILL HAVE THE POTENTIAL TO BURN. NO OTHER SYSMEX DEVICES USE THESE TYPES OF FUSES. NO USERS WERE INJURED OR OTHER AREAS OF THE DEVICE DAMAGED DUE TO THE BURNT FUSE HOLDER. S-CORP ISSUED A COUNTERMEASURE TO THE SUPPLIER TO INCREASE THE TORQUE AND CONFIRM THE CAP IS APPROPRIATELY TIGHTENED. AFTER CONFIRMATION, THE SUPPLIER WILL MARK THE CAP INDICATING THE CAP WAS TIGHTENED AND CONFIRMED.

    Additional Manufacturer Narrative · 1

    THE TS-10 INSTRUCTIONS FOR USE WARN THE USER IN CHAPTER 2 - SAFETY INFORMATION, SECTION 2.1 - GENERAL INFORMATION: "IN THE UNLIKELY EVENT THAT THE SYSTEM EMITS AN UNUSUAL ODOR OR SMOKE, IMMEDIATELY TURN OFF THE MAIN SWITCH AND UNPLUG THE POWER CABLE. THEN CONTACT YOUR SYSMEX SERVICE REPRESENTATIVE. CONTINUED USE OF THE SYSTEM IN SUCH CONDITIONS COULD RESULT IN FIRE, ELECTRICAL SHOCK OR PERSONAL INJURY." IT IS UNKNOWN IF THE TS-10 WAS TURNED OFF AND/OR UNPLUGGED. FUSES ARE LOCATED IN FUSE HOLDERS AT THE BACK OF THE SYSTEM BEHIND A METAL PLATE, NOT READILY ACCESSIBLE TO THE USER. FURTHERMORE, THE FUSE HOLDERS ARE MADE OF FLAME RESISTANT MATERIAL, REDUCING POTENTIAL FOR COMBUSTION. INVESTIGATION BY SYSMEX CORPORATION (B)(6) (S-CORP) IS IN PROCESS.

    Description of Event or Problem · 1

    DURING NORMAL OPERATION, A USER IN (B)(6) NOTED AN ODOR EMANATING FROM THE TUBE SORTER. A SERVICE ENGINEER WAS DISPATCHED AND FOUND ONE FUSE HOLDER TO BE BURNED. REPLACEMENT OF THE AFFECTED FUSE HOLDER RESOLVED THE ISSUE FOR THE USER. THERE WAS NO REPORT OF HARM TO THE OPERATOR OR NEGATIVE IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3071 SYSMEX TS-10 AUTOMATED TUBE SORTER LXG SYSMEX RA CO. LTD. TS-10

    Patients

    Seq Age Sex Outcome Treatment
    1