BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSMEX UF-5000 FULLY AUTOMATED URINE PARTICLE ANALYZER

    MDR report key: 8697169 · Received June 13, 2019

    Report

    Report Number
    1000515253-2019-00014
    Event Type
    Malfunction
    Date Received
    June 13, 2019
    Date of Event
    May 20, 2019
    Report Date
    August 22, 2019
    Manufacturer
    SYSMEX CORPORATION, I SQUARE
    Product Code
    LKM
    UDI-DI
    04987562440139
    PMA / PMN Number
    K171883
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SYSMEX CORPORATION (B)(4) (S-CORP) PERFORMED THE INVESTIGATION. S-CORP DETERMINED THE SAMPLE SPILL ENTERED THE CV-11 CONVEYOR FROM THE BACK LEFT, WHERE THE POWER CORD IS CONNECTED, CAUSING THE SHORT CIRCUIT. S-CORP IS DEVELOPING PLATES AND SPONGES TO ABSORB AND DIVERT LIQUID AWAY FROM THE ELECTRONIC PARTS TO PREVENT RECURRENCE.

    Additional Manufacturer Narrative · 1

    INSPECTION OF THE INSTRUMENT BY A SERVICE ENGINEER (SE) DETERMINED THE URINE SPILL SEEPED INTO CV-11 INSTRUMENT'S POWER CORD OUTLET CAUSING A SHORT CIRCUIT, GENERATING SPARKS, SMOKE AND A BURNING ODOR. THE SYSMEX CV-11 INSTRUCTION FOR USE (IFU), CHAPTER 2 - SAFETY INFORMATION, SECTION 2.1 - GENERAL SAFETY INFORMATION, WARNS THE USER: "IN THE EVENT THE INSTRUMENT EMITS AN ABNORMAL ODOR OR ANY SMOKE, TURN OFF THE POWER SWITCH IMMEDIATELY AND DISCONNECT THE POWER PLUG FROM THE WALL SOCKET. IF THE INSTRUMENT IS USED CONTINUOUSLY IN THAT STATE, THERE IS A POTENTIAL THAT FIRE, ELECTRICAL SHOCK, OR INJURY MAY RESULT. CONTACT YOUR SYSMEX TECHNICAL REPRESENTATIVE FOR INSPECTION. TAKE CARE NOT TO SPILL URINE OR REAGENT OR DROP WIRE STAPLES OR PAPER CLIPS INTO THE INSTRUMENT. THOSE MAY CAUSE A SHORT CIRCUIT OR SMOKE EMISSION. IF SUCH TROUBLE SHOULD OCCUR, TURN OFF THE POWER IMMEDIATELY AND DISCONNECT THE POWER PLUG FROM THE WALL SOCKET. THEN CONTACT YOUR SYSMEX TECHNICAL REPRESENTATIVE FOR INSPECTION". THE SE CONFIRMED WITH THE USER THAT WHEN THE RACK STOPPED IN THE MEASUREMENT LINE, AN ALARM WAS GENERATED. THE USER PRESSED THE "START" SWITCH FROM THE CONTROL PANEL OF THE CV-11 WITHOUT FIRST REMOVING THE RACKS THAT WERE SITUATED ON THE CONVEYOR LINE. THE SYSMEX CV-11 IFU, CHAPTER 8 - TROUBLESHOOTING, SECTION 8.1 - ACTIONS TO RESOLVE ERRORS, INFORMS THE USER: IF AN ERROR OCCURS IN THE CV-11, ST-10 AND ST-11, RESET THE RACK IN THE RIGHT POOL AND CLEAR THE ERROR. THE USER IS INSTRUCTED TO REMOVE THE RACK THAT IS IN THE POSITION INDICATED BY THE LIT RACK POSITION INDICATOR LED, TO CHECK THE NUMBER OF THE ERROR INDICATOR LED AND PERFORM THE ACTIONS CORRESPONDING TO THE NUMBER. IF A FOREIGN OBJECT IS PRESENT, THE USER IS INSTRUCTED TO REMOVE THE FOREIGN OBJECT. ANALYSIS OF THE CV-11 DATA LOGS BY SYSMEX CORPORATION (B)(4) (S-CORP) DETERMINED A RACK CRASH OCCURRED DURING SAMPLE ANALYSIS. THE INSTRUMENT GENERATED AN ERROR. WHEN THE USER PUSHED THE "START" BUTTON WITHOUT REMOVING THE RACKS, A SECOND ERROR WAS GENERATED. THE USER THEN REMOVED THE RACK SITUATED CLOSEST TO THE LEFT RACK POOL AND PUSHED THE "START" BUTTON AGAIN. THE SECOND RACK WAS MOVED TO THE LEFT TOWARDS THE LEFT RACK POOL. THE CV-11 UTILIZES A FRONT AND REAR BELT TO TRANSPORT A RACK. THE RACKS ARE SANDWICHED BETWEEN BELT PROTRUSIONS. THE BELT PROTRUSIONS AID IN SIGNALING THE HOMING POSITION OF THE BELT TO THE SENSOR. THE SECOND RACK TIPPED OVER AND SPILLED SAMPLE ONTO THE LEFT POOL RACK WHEN THE TRANSPORT MECHANISM PUSHED THE RACK ONTO THE BELT PROTRUSION. INVESTIGATION BY SYSMEX CORPORATION (B)(4) (S-CORP) IS IN PROCESS.

    Description of Event or Problem · 1

    IN (B)(6), THE USER OF A SYSMEX UF-5000 AUTOMATED URINE PARTICLE ANALYZER WITH A CV-11, URINE SAMPLE TRANSPORTATION UNIT, SERIAL NUMBER (SN) (B)(4), REPORTED SPARKS, SMOKE AND A BURNING ODOR COMING FROM THE CV-11 FOLLOWING A SPILL FROM A RACK OF URINE SAMPLES. THE USER REPORTED THAT THE CV-11 HAD CEASED OPERATION UNEXPECTEDLY, PROMPTING A RE-INITIALIZATION. UPON RE-INITIALIZATION, THE SAMPLE RACK WAS PUSHED TOWARDS THE LEFT RACK POOL AREA THAT COLLECTS SAMPLES AFTER ANALYSIS AND TIPPED OVER, SPILLING THE URINE ONTO THE CONVEYOR. THE USER IMMEDIATELY CLEANED THE AREA, BUT WITHIN AN HOUR OF THE SPILL, THE USER NOTED SPARKS, SMOKE AND A BURNING ODOR COMING FROM THE CV-11. A FIRE EXTINGUISHER WAS DEPLOYED AT THE SOURCE OF THE SMOKE. THERE WERE NO REPORTS OF HARM TO THE USERS OR PATIENTS DUE TO THE EVENT. A NEW CV-11 WAS INSTALLED TO RESOLVE THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    490591 SYSMEX UF-5000 FULLY AUTOMATED URINE PARTICLE ANALYZER URINE PARTICLE COUNTER LKM SYSMEX CORPORATION, I SQUARE UF-5000 04987562440139

    Patients

    Seq Age Sex Outcome Treatment
    1