BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 750 SLIDEMAKER

    MDR report key: 2528840 · Received April 11, 2012

    Report

    Report Number
    1061932-2012-01244
    Event Type
    Malfunction
    Date Received
    April 11, 2012
    Date of Event
    March 17, 2012
    Report Date
    March 17, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKJ
    PMA / PMN Number
    CL. I EXEMPT
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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. A BEC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON (B)(4) 2012. THE FSE FOUND THE RINSE TUBING FROM THE RINSE BLOCK (RB1) WAS PARTIALLY PLUGGED. THE RINSE TUBING AND CONNECTOR WERE REPLACED. THE CAUSE OF THE LEAK IS PLUGGED RINSE BLOCK RINSE TUBING. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC., (BEC) AND REPORTED A LIQUID LEAK AROUND THE DISPENSE PROBE ON THE COULTER LH 750 SLIDEMAKER. THE VOLUME OF THE LEAK WAS APPROXIMATELY 5ML WHICH WAS CONTAINED WITHIN THE INSTRUMENT. THE CUSTOMER COULD NOT LOCATE THE EXACT SOURCE OF THE LEAK. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF A LAB COAT, GLOVES WITH NO FACE PROTECTION. THE OPERATOR NEVER CAME IN CONTACT WITH THE LIQUID. 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; HOWEVER, IT IS READILY AVAILABLE ON THE BECKMAN COULTER, INC. WEBSITE. THERE IS AN EXPOSURE CONTROL/RISK MANAGEMENT PLAN IN PLACE AT THE FACILITY. THERE WAS NO IMPACT TO PATIENT RESULTS. 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 GKJ BECKMAN COULTER, INC. N/A

    Patients

    Seq Age Sex Outcome Treatment
    1