BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 750 HEMATOLOGY ANALYZER

    MDR report key: 2367838 · Received December 12, 2011

    Report

    Report Number
    1061932-2011-02642
    Event Type
    Malfunction
    Date Received
    December 12, 2011
    Date of Event
    November 12, 2011
    Report Date
    November 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
    CA
    Reporter Occupation
    OTHER

    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. PER FIELD SERVICE ENGINEER (FSE) E-MAIL FROM (B)(4) 2011, THE RETIC CLEAR CHAMBER WAS CRACKED ON THE BOTTOM AND WAS LEAKING. THIS HAPPENED DURING A STAR-UP SO THE RETIC MIXING CHAMBER WOULD CONTAIN RETIC CLEARING SOLUTION AND STAIN. THE PROBLEM WAS FIXED WITH THE REPLACEMENT CHAMBER AND THE INSTRUMENT WAS OPERATING WITHIN SPECIFICATIONS. THE ROOT CAUSE OF THE LEAK IS ATTRIBUTED TO A CRACK IN THE BOTTOM OF THE RETIC MIXING CHAMBER. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC., (BEC) AND REPORTED A LEAK OF APPROXIMATELY 20 ML OF CLEAR FLUID DRIPPING FROM UNDERNEATH THE COULTER LH 750 HEMATOLOGY ANALYZER. THE MATERIAL SAFETY DATA SHEET (MSDS) WAS NOT REVIEWED; HOWEVER, IT IS READILY AVAILABLE. THE LAB'S RISK MANAGEMENT PLANS ARE IN PLACE AT THE FACILITY. CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF A LAB COAT AND GLOVES AT THE TIME OF THE EVENT. THERE WAS NO EXPOSURE TO MUCOUS MEMBRANE OR OPEN WOUNDS. MEDICAL ATTENTION WAS NOT SOUGHT. THE LEAK OCCURRED DURING A START-UP AND NO PATIENT RESULTS WERE AFFECTED. NO DEATH OR INJURY IS ATTRIBUTED TO THIS EVENT, AND THERE WAS NO CHANGE TO PATIENT TREATMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1