BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 750 HEMATOLOGY ANALYZER

    MDR report key: 3122459 · Received May 21, 2013

    Report

    Report Number
    1061932-2013-00909
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Date of Event
    April 23, 2013
    Report Date
    April 23, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K061574
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BEC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON (B)(4) 2013 FOR THIS EVENT. THE FSE INDICATED THAT THE INSTRUMENT WAS DRIPPING A FEW DROPS OF BACKWASH DILUENT FROM THE SECONDARY ASPIRATION PROBE WHEN THE INSTRUMENTS COMPRESSOR SHUTS DOWN DUE TO A PROGRAMMED SHUTDOWN OR WHEN THE IDLE TIMER TIMES OUT AND SHUTS DOWN THE COMPRESSOR. THE FSE FOUND THE NEEDLE BACKWASH LINE WAS CAUSING THE PROBLEM. THE FSE REPLACED THE NEEDLE BACKWASH DILUENT PUMP AND THE ASSOCIATED TUBING FROM THE BACKWASH MANIFOLD 4 TO PINCH VALVE (PV) 59. THE FSE ALSO FOUND THAT THE LIGHT SCATTER OFFSET VOLTAGE WAS TOO HIGH ON STARTUP. THE FSE THEN CLEANED THE FLOWCELL AND BROUGHT THE BACKGROUND OFFSET VOLTAGE BACK INTO SPECIFICATION. FAILURE MODE: NEEDLE BACKWASH DILUENT PUMP AND ASSOCIATED TUBING WHICH NEEDED TO BE REPLACED. PER LABELING, BECKMAN COULTER URGES ITS CUSTOMERS TO COMPLY WITH ALL NATIONAL HEALTH AND SAFETY STANDARDS SUCH AS THE USE OF BARRIER PROTECTION. THIS MAY INCLUDE, BUT IS NOT LIMITED TO PROTECTIVE EYEWEAR, GLOVES AND SUITABLE LABORATORY ATTIRE WHEN OPERATING OR MAINTAINING THIS OR ANY OTHER AUTOMATED LABORATORY ANALYZER. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER (BEC) REPORTING THAT THE PROBE IN THE COULTER LH 750 HEMATOLOGY ANALYZER STATION HAS BEEN LEAKING CLEAR FLUID SINCE THE PREVENTIVE MAINTENANCE (PM) PROCEDURE WAS PERFORMED LAST WEEK. THE VOLUME OF THE LEAK WAS LESS THAN 1 ML (ABOUT THREE DROPS) AND WAS NOT CONTAINED WITHIN THE INSTRUMENT. THE OPERATOR WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF GLOVES AND A LABORATORY COAT AT THE TIME OF THE INCIDENT. 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 BIOHAZARD EXPOSURE TO MUCOUS MEMBRANES OR OPEN WOUNDS. MEDICAL ATTENTION WAS NOT SOUGHT. NO ERRONEOUS RESULTS WERE GENERATED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224644 COULTER® LH 750 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER LH 750 NA

    Patients

    Seq Age Sex Outcome Treatment
    1