BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSMEX CS-2100I AUTOMATED COAGULATION ANALYZER

    MDR report key: 8853077 · Received August 1, 2019

    Report

    Report Number
    1000515253-2019-00016
    Event Type
    Malfunction
    Date Received
    August 1, 2019
    Date of Event
    July 18, 2019
    Report Date
    October 11, 2019
    Manufacturer
    SYSMEX CORPORATION, I SQUARE
    Product Code
    JPA
    UDI-DI
    04987562409471
    PMA / PMN Number
    K162688
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    RETURN OF THE SUSPECT PARTS FOR INVESTIGATION OF ROOT CAUSE WAS REQUESTED. IT WAS REPORTED THAT THE SUSPECT PARTS WERE LOST DURING TRANSPORT AND WERE NO LONGER AVAILABLE. AN INVESTIGATION COULD NOT BE PERFORMED. ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED. BASED ON THE DATA PROVIDED, SYSMEX CORPORATION JAPAN (S-CORP) DETERMINED IT IS POSSIBLE PINCHING OF WIRING CORD 3834 CONTRIBUTED TO THE EVENT. THIS IS AN ISOLATED EVENT, AS NO SIMILAR ISSUE INVOLVING THIS PART WAS REPORTED. NO FURTHER CORRECTIVE ACTION WILL BE TAKEN.

    Additional Manufacturer Narrative · 1

    SYSMEX CORPORATION (B)(4) CONFIRMED THAT THERE IS NO RISK OF FIRE SHOULD THIS EVENT RECUR. THE WIRING CORD IS MANUFACTURED USING FLAME RETARDANT MATERIAL AND IS COVERED BY A SHEET METAL ENCLOSURE. THE WIRING CORDS ARE NOT ACCESSIBLE TO THE USER. THE MAXIMUM VOLTAGE TRAVELING THROUGH THE WIRING CORD IS 5V. THE LOW VOLTAGE REDUCES THE POTENTIAL FOR SHOCK. THE CS-2000I / CS-2100I INSTRUCTIONS FOR USE (IFU), INSTRUCT THE USER IN CHAPTER 2 - SAFETY INFORMATION, SECTION 2.2-GENERAL INFORMATION: "SHOULD THE INSTRUMENT EMIT ANY UNUSUAL ODORS OR SMOKE, TURN THE MAIN SWITCH OFF IMMEDIATELY AND UNPLUG THE POWER CABLE. CONTACT YOUR LOCAL SYSMEX TECHNICAL REPRESENTATIVE. FAILURE TO DO SO COULD RESULT IN FIRE, ELECTRICAL SHOCK OR INJURY. " THE USER FOLLOWED THE INSTRUCTIONS AND DISCONNECTED THE ANALYZER FROM THE POWER SUPPLY WHEN THE ODOR WAS FIRST DETECTED.

    Description of Event or Problem · 1

    THE USER REPORTED A BURNT ODOR EMANATING FROM THE ANALYZER. THE USER IMMEDIATELY TURNED OFF AND DISCONNECTED THE ANALYZER FROM THE POWER SUPPLY. THERE WAS NO REPORT OF HARM TO THE OPERATOR. A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO INSPECT THE ANALYZER. THE FSE FOUND MELTING AND CHARRING OF WIRING CORD 3834. WIRING CORD 3834 CONNECTS THE HALL ELEMENT NO. 7 ASSEMBLY TO PCB NO. 1278. THE FSE INSTALLED A NEW SAMPLE TABLE ASSEMBLY, REPLACED THE MIXING MOTORS AND HALL EFFECT SENSORS, ADJUSTED ALL TEMPERATURES AND PERFORMED NECESSARY SAMPLE ARM AND REAGENT ARM ADJUSTMENTS. THE FSE ADJUSTED THE CATCHER TO THE DISPENSING WHEEL, PERFORMED ALL ADJUSTMENTS AND CHECKED THE TEMPERATURE. THE FSE THEN RAN QC AND DEEMED THE ANALYZER OPERATIONAL. PART REPLACEMENT AND EVIDENCE BASED MAINTENANCE RESOLVED THE ISSUE FOR THE USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    647099 SYSMEX CS-2100I AUTOMATED COAGULATION ANALYZER CS-2100I JPA SYSMEX CORPORATION, I SQUARE CS-2100I 04987562409471

    Patients

    Seq Age Sex Outcome Treatment
    1