BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSMEX TS-10

    MDR report key: 9541146 · Received January 2, 2020

    Report

    Report Number
    1000515253-2020-00001
    Event Type
    Malfunction
    Date Received
    January 2, 2020
    Date of Event
    December 6, 2019
    Report Date
    March 4, 2020
    Manufacturer
    SYSMEX RA CO. LTD.
    Product Code
    LXG
    UDI-DI
    04987562433155
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE TS-10 INSTRUCTIONS FOR USE (IFU), CHAPTER 2 - SAFETY INFORMATION, SECTION 2.1 - GENERAL INFORMATION, STATES, "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." THE TS-10 WAS UNPLUGGED AFTER THE ODOR WAS OBSERVED. 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)(4) (S-CORP) IS IN PROCESS. THE SE REPLACED THE FUSE HOLDER TO RESOLVE THE ISSUE.

    Additional Manufacturer Narrative · 1

    SYSMEX CORPORATION (B)(4) (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.

    Description of Event or Problem · 1

    A USER IN (B)(6) REPORTED A BURNING ODOR EMANATING FROM THE TUBE SORTER. A SERVICE ENGINEER (SE) WAS DISPATCHED THE NEXT DAY AND FOUND THE FUSE HOLDER WAS BURNT. NO SMOKE OR FIRE WAS OBSERVED. NO USER OR PATIENT HARM WAS INCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4679 SYSMEX TS-10 AUTOMATED TUBE SORTER LXG SYSMEX RA CO. LTD. TS-10 04987562433155

    Patients

    Seq Age Sex Outcome Treatment
    1