BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SP-10

    MDR report key: 11091980 · Received December 29, 2020

    Report

    Report Number
    1000515253-2020-00033
    Event Type
    Malfunction
    Date Received
    December 29, 2020
    Date of Event
    December 17, 2020
    Report Date
    February 10, 2021
    Manufacturer
    SYSMEX CORPORATION, I SQUARE
    Product Code
    KPA
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    SYSMEX CORPORATION JAPAN (S-CORP) DETERMINED THERE WAS INCREASED ELECTRICAL RESISTANCE BETWEEN THE INLET TO THE PNEUMATIC UNIT AND THE FEMALE END OF THE POWER CORD POSSIBLY DUE TO THE POWER CORD NOT BEING SEATED COMPLETELY. THIS CAUSED THE POWER CORD TO OVERHEAT AND MELT. NO SYSTEMIC PRODUCT DEFICIENCY WAS IDENTIFIED.

    Additional Manufacturer Narrative · 1

    THE ANALYZER GENERATED PRESSURE ERRORS. THE SP-10 TROUBLESHOOTING IFU, CHAPTER 10 - TROUBLESHOOTING - CAUSES OF ERRORS AND REMEDIAL ACTIONS, DISPLAYS THE VARIOUS PRODUCIBLE ERRORS, AND THE MEANINGS ASSOCIATED WITH THE ERRORS. THE "PRESSURE ERROR" HAS THE FOLLOWING PROBABLE CAUSES: DURING STARTUP, SHUTDOWN, OR CLEANING, ANOTHER ERROR (PRESSURE ERROR, ETC.) PREVENTED THE NEXT OPERATION FROM BEING PERFORMED. THE CASSETTE HAS STOPPED IN THE STAIN POOL DUE TO DIRT ON THE CASSETTE. THE USER IS TO: RESOLVE THE OTHER ERROR, AND THEN FOLLOW THE INSTRUCTIONS IN THE ACTION MESSAGE TO RESET. CLEAN THE CASSETTE, AND THEN FOLLOW THE INSTRUCTIONS IN THE ACTION MESSAGE TO RESET. THE SP-10 GENERAL INFORMATION INSTRUCTIONS FOR USE (IFU), CHAPTER 2 - SAFETY INFORMATION, SECTION 2.1 - GENERAL INFORMATION, STATES, "SHOULD THE DEVICE EMIT UNUSUAL ODORS OR SMOKE, TURN OFF THE POWER IMMEDIATELY AND UNPLUG THE POWER CABLE. CONTACT YOUR LOCAL SYSMEX REPRESENTATIVE. CONTINUING TO USE THE DEVICE MAY RESULT IN FIRE, ELECTRICAL SHOCK, OR INJURY". ADDITIONALLY, "DO NOT DAMAGE THE POWER CABLE. DO NOT PLACE ANY HEAVY OBJECTS ON THE POWER CABLE OR FORCIBLY PULL ON THE POWER CABLE. RISK OF FIRE AND ELECTRICAL SHOCK DUE TO SHORT-CIRCUITING OR WIRE BREAKAGE." THE USER APPROPRIATELY CONTACTED THE SYSMEX TECHNICAL ASSISTANCE CENTER AFTER OBSERVING THE MELTED CABLE. A SYSMEX SERVICE ENGINEER WAS DISPATCHED AND REPORTED THE POWER CORD DID NOT APPEAR TO BE COMPLETELY PLUGGED INTO THE PU-17. THE SERVICE ENGINEER REPLACED THE PU-17 AND POWER CORD TO RESOLVE THE ISSUE. THE SUSPECT PU-17 AND POWER CORD WILL BE EXAMINED BY SYSMEX CORPORATION (B)(4) (S-CORP) FOR INVESTIGATION OF ROOT CAUSE.

    Description of Event or Problem · 1

    THE USER OF AN AUTOMATIC SLIDE PREPARER (SP-10) REPORTED THE DEVICE WAS GENERATING PRESSURE ERRORS. DURING TROUBLESHOOTING, THE USER OPENED THE SP-10 WAGON DOOR WHERE THE PNEUMATIC UNIT (PU-17) IS LOCATED, AND STATED THE POWER CORD CONNECTED TO THE PU-17 APPEARED MELTED. THERE WAS NO VISIBLE SMOKE, FLAME OR ODOR. THERE WAS NO OPERATOR HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1550650 SP-10 SP-10 AUTOMATED HEMATOLOGY SLIDE PREPARATION UNIT KPA SYSMEX CORPORATION, I SQUARE SP-10

    Patients

    Seq Age Sex Outcome Treatment
    1