BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CA-1500

    MDR report key: 9776930 · Received March 2, 2020

    Report

    Report Number
    1000515253-2020-00008
    Event Type
    Malfunction
    Date Received
    March 2, 2020
    Date of Event
    February 17, 2020
    Report Date
    March 2, 2020
    Manufacturer
    SYSMEX RA CO. LTD.
    Product Code
    JPA
    PMA / PMN Number
    K011235
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) WAS DISPATCHED AND FOUND A BURNT WIRE. THE CSE OBSERVED THE WIRE WAS PINCHED BY THE CHASSIS OF THE ANALYZER BETWEEN SHEET METAL COMPONENTS. THE CHASSIS OF THE ANALYZER IS GROUNDED TO EARTH. THE CSE REMOVED THE SUSPECT WIRE FROM THE AFFECTED WIRING CORD 2513 TO RESOLVE THE ISSUE. THE FUNCTION AND SAFETY OF THE ANALYZER IS NOT AFFECTED BY REMOVING THIS WIRE. THE OTHER WIRES IN THE WIRING CORD WERE UNDAMAGED. THE SUSPECT WIRE HAS NO FUNCTION IN THE CA-1500, BUT HAS 12 VOLTS OF DIRECT CURRENT (VDC) APPLIED. THE WIRING CORD IS MADE OF FLAME RESISTANT MATERIALS, BUT EXCESSIVE HEAT FROM A MALFUNCTION POSES A RISK OF INHALATION OF SMOKE AND/OR HARMFUL VAPORS FROM SCORCHED MATERIALS. THE CA-1500 SYSTEM OPERATOR'S MANUAL, 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 THIS STATE, THERE IS A POTENTIAL THAT FIRE, ELECTRICAL SHOCK, OR INJURY MAY RESULT. CONTACT YOUR SERVICE REPRESENTATIVE FOR INSPECTION." THE USER APPROPRIATELY SHUT DOWN THE ANALYZER AND CONTACTED SIEMENS HEALTHCARE DIAGNOSTICS. THE WIRING CORD WAS NOT AVAILABLE FOR FURTHER INVESTIGATION. SYSMEX CORPORATION (B)(4) (S-CORP) REVIEWED THE DATA AND CONFIRMED THIS TO BE AN ISOLATED EVENT. NO SYSTEMIC ANALYZER DEFICIENCY WAS IDENTIFIED.

    Description of Event or Problem · 1

    THE USER OBSERVED SMOKE EMANATING FROM THE ANALYZER WHEN ATTEMPTING TO CLEAR A JAM IN THE CUVETTE HOPPER. THE USER IMMEDIATELY SHUT DOWN THE ANALYZER. THERE WAS NO REPORT OF HARM TO THE USER OR NEGATIVE IMPACT TO PATIENT CARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    239568 CA-1500 CA-1500 AUTOMATED COAGULATION ANALYZER JPA SYSMEX RA CO. LTD. CA-1500

    Patients

    Seq Age Sex Outcome Treatment
    1