BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVO-2 200 MCA

    MDR report key: 3505549 · Received November 19, 2013

    Report

    Report Number
    3003402518-2013-00007
    Event Type
    Injury
    Date Received
    November 19, 2013
    Date of Event
    November 1, 2013
    Report Date
    November 1, 2013
    Manufacturer
    TECAN SCHWEIZ
    Product Code
    JQW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A TECAN FIELD SERVICE ENGINEER (FSE) WENT TO THE LABORATORY TO AVAILABLE THE INSTRUMENT. THE LABORATORY HAD MECHANICALLY DISABLED THE DOOR LOCKS ON THE INSTRUMENT. WHEN THE DOOR LOCKS ARE ENGAGED ON THE INSTRUMENT AND THE PAUSE BUTTON IS PRESSED, THE DOOR LOCKS WILL NOT OPEN AND NOT ALLOW ACCESS UNTIL THE INSTRUMENT HAS COMPLETED ALL MOVES THAT ARE IN PROCESS OR ALREADY SENT VIA A COMMAND. IN THIS CASE, THE PAUSE BUTTON WAS PRESSED AND THE DOOR LOCKS WERE DEFEATED ALLOWING THE OPERATOR TO GAIN ACCESS PRIOR TO ALL OF THE MOVES BEING COMPLETED. THIS RESULTED IN AN INJURY TO THE INSTRUMENT OPERATOR WHEN THEY REACHED INTO THE INSTRUMENT TO REMOVE TIPS STUCK TO THE MCA PIPETTING HEAD. THE TECAN FSE RECONFIGURED THE DOOR LOCKS AND RAN DIAGNOSTIC TEST. ALL SAFETY TESTS PASSED INCLUDING DOOR LOCKS, PAUSE/RESUME FUNCTION, AND ACOUSTIC ALARM. THERE WAS NO MALFUNCTION. TECAN INSTALLS INSTRUMENTS WITH DOOR LOCKS ENABLED.

    Description of Event or Problem · 1

    LABORATORY CALLED TECAN ON (B)(6) TO REPORT THAT DURING A TEST RUN OF A EVO 200 MCA LIQUID HANDLING PIPETTOR INSTRUMENT, THE OPERATOR HAD PRESSED THE PAUSE BUTTON AND REACHED INSIDE THE INSTRUMENT TO REMOVE TIPS THAT WERE STUCK TO THE MCA HEAD. THE PAUSE BUTTON WAS LIT INDICATING INSTRUMENT WAS PAUSED. WHILE THE OPERATOR'S HAND WAS INSIDE THE INSTRUMENT, THE MCA HEAD MOVED DOWN PINNING THE OPERATOR'S HAND TO THE DECK OF THE INSTRUMENT. THE OPERATOR HIT THE PAUSE BUTTON TO UNPAUSE THE INSTRUMENT AND THE MCA HEAD MOVED UP FREEING THE OPERATOR'S HAND. THE OPERATOR SUSTAINED MINOR INJURY TO THE HAND INCLUDING A CUT WITH BLEEDING. NO MEDICAL TREATMENT WAS REQUIRED OTHER THAN BASIC FIRST AID. THE TEST RUN WAS WITHOUT REAGENTS AND THE TIPS WERE CLEAN AND STERILE. NO RISK OF BIOHAZARD EXPOSURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    598202 EVO-2 200 MCA PIPETTING STATION FOR CLINICAL USE JQW TECAN SCHWEIZ

    Patients

    Seq Age Sex Outcome Treatment
    1 Other