BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 750 SLIDEMAKER

    MDR report key: 2480744 · Received March 6, 2012

    Report

    Report Number
    1061932-2012-00809
    Event Type
    Malfunction
    Date Received
    March 6, 2012
    Date of Event
    February 13, 2012
    Report Date
    February 13, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    CL. I EXEMPT
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A BEC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON (B)(4) 2012 FOR THIS EVENT. THE FSE FOUND THE LEAK WAS DUE TO A CUT TUBING AND REPLACED IT. PER E-MAILS FROM THE FSE, THE LEAKING TUBING WAS THE RED STRIPE I-BEAM TUBING THROUGH VALVE LINE 8 (VL8) AND DISPENSE PROBE 1 (DP1) IN THE SLIDEMAKER. THE LEAK WAS AT THE PINCH VALVE AND THERE WAS BLOOD AT THE PINCH VALVE ON THE OUTSIDE OF THE TUBING AND IN THE DRIP TRAY. THE TUBING WAS VISIBLE TO THE CUSTOMER UPON OPENING THE DOOR, BUT NO ONE TOUCHED THE BLOOD OR THE TUBING. AS SOON AS THE LEAK WAS DISCOVERED THE INSTRUMENT WAS TURNED OFF BY THE CUSTOMER AND NOT USED UNTIL THE FSE REPAIRED THE INSTRUMENT. THE TUBING IS RINSED WITH DILUENT BETWEEN SPECIMENS AND DURING A STARTUP, AND RINSED WITH CLENZ DURING SHUTDOWN. PER LABELING, BECKMAN COULTER, INC. URGES ITS CUSTOMERS TO COMPLY WITH ALL NATIONAL HEALTH AND SAFETY STANDARDS SUCH AS THE USE OF BARRIER PROTECTION. THIS MAY INCLUDE, BUT IT IS NOT LIMITED TO, PROTECTIVE EYEWEAR, GLOVES, AND SUITABLE LABORATORY ATTIRE WHEN OPERATING OR MAINTAINING THIS OR ANY OTHER AUTOMATED LABORATORY ANALYZER. THE CAUSE OF THE LEAK IS A CUT TUBING THROUGH VL8 AND DP1. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC., (BEC) AND REPORTED A FLUID LEAK OF 50ML OF DILUENT/BLOOD INSIDE OF THE COULTER LH 750 SLIDEMAKER UNIT. THE CUSTOMER COULD NOT LOCATE THE EXACT SOURCE OF THE LEAK AREA NEAR A PINCH VALVE AND SERVICE WAS REQUESTED. THE LEAK WAS CONTAINED INSIDE THE INSTRUMENT. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF A GOWN, GLOVES AND SAFETY GLASSES. THERE WAS NO EXPOSURE TO MUCOUS MEMBRANES OR OPEN WOUNDS AND MEDICAL ATTENTION WAS NOT SOUGHT. THE MATERIAL SAFETY DATA SHEET (MSDS) WAS NOT REVIEWED. THERE IS AN EXPOSURE CONTROL/RISK MANAGEMENT PLAN IN PLACE AT THE FACILITY. THERE WAS NO IMPACT TO PATIENT RESULTS. NO SLIDES WERE MADE AT THIS TIME. THERE WAS NO DEATH, INJURY OR CHANGE TO PATIENT TREATMENT ATTRIBUTED OR ASSOCIATED TO THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER® LH 750 SLIDEMAKER SPINNER, SLIDE, AUTOMATED GKZ BECKMAN COULTER, INC. LH750 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1