BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BECKMAN COULTER ¿ COULTER ® LH 750 HEMATOLOGY ANALYZER

    MDR report key: 2298539 · Received October 17, 2011

    Report

    Report Number
    1061932-2011-01781
    Event Type
    Malfunction
    Date Received
    October 17, 2011
    Date of Event
    September 11, 2011
    Report Date
    September 12, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    GKZ
    PMA / PMN Number
    K011342
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BECKMAN COULTER INC (BEC) TO REPORT A LEAK FROM UNDER THE LH750 SLIDEMAKER. THE CUSTOMER WAS UNABLE TO LOCATE THE SOURCE OF THE LEAK. THE CUSTOMER STATED THE RIGHT DRIP TRAY IS FILLING WITH CLEAR FLUID. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF A LAB COAT, EYE PROTECTION, AND GLOVES. NO REPORT OF EXPOSURE (SPLASHED OR SPAYED) TO MUCOUS MEMBRANES OR OPEN WOUNDS WAS REPORTED. NO DEATH, INJURY OR CHANGE TO PATIENT TREATMENT ATTRIBUTED OR ASSOCIATED TO THIS COMPLAINT. SINCE THE EVENT IS RELATED ONLY TO THE SLIDE-MAKER, SAMPLE RESULTS WERE NOT IMPACTED AS A RESULT OF THIS EVENT. THE CUSTOMER DID NOT SEEK MEDICAL ATTENTION. ON THE DATE OF THE EVENT, A BEC FIELD SERVICE ENGINEER (FSE) NOTED THE LEAK WAS COMING OUT OF THE SIDE OF THE INSTRUMENT. UPON INSPECTION, THE FSE FOUND THAT LEAK STEMMED FROM A CUT TUBE GOING THROUGH PINCH VALVE (VL20). VL20 PROVIDES PRESSURIZED DILUENT TO THE RINSE BLOCK AND DISPENSE LINES. FSE REPLACED TUBING AND CLEANED TRUCK GUIDE RODS AND ADJUSTED TRUCK SENSORS, WHICH RESOLVED THE ISSUE AND NO FURTHER LEAK WAS NOTED. REPAIRS WERE VERIFIED AS PER ESTABLISHED PROCEDURES AND MEET PUBLISHED PERFORMANCE SPECIFICATIONS. ROOT CAUSE FOR THE LEAK WAS CUT TUBING GOING THROUGH PINCH VALVE (VL) 20.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BECKMAN COULTER ¿ COULTER ® LH 750 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER INC. LH750 SM N/A

    Patients

    Seq Age Sex Outcome Treatment
    1