BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYSMEX CA-1500 CP

    MDR report key: 5513971 · Received March 21, 2016

    Report

    Report Number
    1000515253-2016-00007
    Event Type
    Injury
    Date Received
    March 21, 2016
    Date of Event
    February 24, 2016
    Report Date
    March 11, 2016
    Manufacturer
    SYSMEX CORPORATION
    Product Code
    GKP
    PMA / PMN Number
    K993299
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    AN OPERATOR IN (B)(6) WAS INJURED WHILE ATTEMPTING TO CLEAR A REACTION TUBE JAM ON THE ANALYZER. THE SAMPLE PROBE WENT INTO THE INDEX FINGER OF ONE HAND. THE OPERATOR OPENED THE LIGHT SHIELD LID TO CLEAR A REACTION TUBE JAM. THE TECHNOLOGIST STATED THAT BECAUSE THE LIGHT SHIELD LID HAD BEEN OPENED HE DID NOT EXPECT THE ANALYZER TO MOVE, BUT THERE WAS MECHANICAL MOVEMENT WITH THE LID OPEN. THIS IS WHEN THE INJURY OCCURRED. THE OPERATOR WENT TO THE EMERGENCY ROOM AFTER THE INCIDENT AT 4:00PM AND WAS TREATED WITH A TETANUS SHOT AND BLOOD TESTS FOR (B)(6). IT IS UNKNOWN IF ANTI-VIRAL MEDICATIONS WERE PRESCRIBED. THE INJURED TECHNOLOGIST WAS TOLD NOT TO WORK FOR A FEW DAYS AFTER THE INJURY BUT, WENT BACK TO WORK AND FINISHED HIS REMAINING SHIFT. A CUSTOMER SERVICE ENGINEER (CSE) WAS DISPATCHED AND ARRIVED AT FACILITY ON 2/25/16 AT 10:00AM. THE ENGINEER REPLACED THE SAMPLE PROBE; REMOVED THE VESSEL FEEDER AND TIGHTENED THE SET SCREW ON THE MOTOR SHAFT. THE ENGINEER EXAMINED THE LIGHT SHIELD LID SENSOR ON THIS ANALYZER ((B)(4)) AND THE LAB'S ALTERNATE CA-1500 ANALYZER ((B)(4)). THE SENSORS FOR THE LIGHT SHIELD LIDS ON BOTH ANALYZERS WERE WORKING HOWEVER THE METAL TABS THAT MOVE IN AND OUT OF THE SENSOR WERE NOT CLEARING THE SENSOR BEAM. SO WHEN THE LID WAS OPENED, THE ANALYZERS DID NOT REGISTER THE LID AS OPEN, AND STOP MECHANICAL MOVEMENT. THE ENGINEER BENT THE METAL TABS OUTWARD TO RESOLVE THE ISSUE SO THAT WHEN THE LID WAS OPENED, THE TABS WOULD CLEAR THE SENSOR BEAM. HE DOES NOT KNOW HOW THE METAL TABS MAY HAVE BECOME OUT OF ALIGNMENT. THE LIGHT SHIELD LID SENSORS WERE NOT OVERRIDDEN OR INACTIVATED WHEN THE CSE EXAMINED THE SENSORS. THERE IS NO KNOWN HISTORY OF LID SENSOR ISSUES AT THIS ACCOUNT. THE CSE REPORTED THAT THE LID STATUS INDICATOR ON THE MAIN SCREEN WAS RED (NOT GREEN) WHEN THE OPERATOR OPENED THE LID, INDICATING THAT THE LID SHOULD NOT BE OPENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    169719 SYSMEX CA-1500 CP AUTOMATED BLOOD COAGULATION ANALYZER GKP SYSMEX CORPORATION CA-1500 CP

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention