BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BECKMAN COULTER LAB AUTOMATION SYSTEM

    MDR report key: 2008270 · Received March 6, 2011

    Report

    Report Number
    2050012-2011-00584
    Event Type
    Injury
    Date Received
    March 6, 2011
    Date of Event
    February 1, 2011
    Report Date
    February 3, 2011
    Manufacturer
    BECKMAN COULTER BIOMEDICAL GMBH
    Product Code
    JQP
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ERROR IS MANUALLY REPRODUCABLE IN-HOUSE. DURING NORMAL OPERATION THE ERROR CAN BE CAUSED BY A TUBE JAM IN THE TUBE SEPARATION UNIT OF THE AUTOMATE. THE JAMMED TUBES PRECLUDED THE MECHANISM FROM CLOSING. THE OPERATOR REMOVED THE JAMMED TUBES BY PRESSING THEM OUT WITH HER FINGER, BUT WHEN THE TUBES GET FREE THE MECHANISM IMMEDIATELY CLOSES UNTIL IT WAS STOPPED BY THE OPERATOR'S FINGER. WHEN SHUTTING DOWN THE SYSTEM THERE IS STILL RESIDUAL PRESSURE IN THE SYSTEM WHICH CAN ONLY BE REMOVED BY OPENING THE OUTLET VALVE OF THE COMPRESSOR OR BY ACTIVATING THE MECHANISM ON THE PNEUMATIC UNIT (WHICH IS ONLY DONE BY FIELD SERVICE ENGINEER (FSE), USER IS NOT AWARE OF THIS). IN THIS CASE AN IN-HOUSE ENGINEER ACTIVATED THE OUTLET VALVE OF THE COMPRESSOR TO FREE THE OPERATOR AFTER ABOUT 15 MINUTES. THE ERROR CASE THAT LEAD TO THE EVENT IS NOT DISPLAYED IN THE INSTRUCTION FOR USE OF THE AUTOMATE 2500 SYSTEMS.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) TO REPORT AN OPERATOR INJURED HER FINGER WHILE ATTEMPTED TO REMOVE A JAMMED TUBES ON THE BECKMAN COULTER LAB AUTOMATION SYSTEM AUTOMATE 1250. THE OPERATOR ATTEMPTED TO RECOVER THE SYSTEM FROM BLOCKING TUBES IN THE TUBE SEPARATION UNIT OF THE AUTOMATE. TWO SECONDARY TUBES WERE PINCHED IN A GAP OF ABOUT 10X0.8 CM. THE DEFAULT POSITION OF THE MECHANISM IS CLOSED AND IT IS OPENED PNEUMATICALLY TO SEPARATE SINGLE SECONDARY TUBES. A FORCE OF ABOUT 6 BAR OF THE COMPRESSOR WHICH SPREADS ON A 10 CM WIDE MOVING PART IS RESPONSIBLE FOR CLOSING THE MECHANISM AND HOLDING IT IN CLOSED POSITION. THE OPERATOR WAS TAKEN TO THE HOSPITAL FOR X-RAY. ALTHOUGH, THE OPERATOR DID NOT SUFFER BROKEN BONES, SHE DID INJURE HER FINGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BECKMAN COULTER LAB AUTOMATION SYSTEM LAB AUTOMATION JQP BECKMAN COULTER BIOMEDICAL GMBH AUTOMATE 1250 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization