BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 750 HEMATOLOGY ANALYXZER

    MDR report key: 3122428 · Received May 21, 2013

    Report

    Report Number
    1061932-2013-00879
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Date of Event
    April 26, 2013
    Report Date
    April 26, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K011342
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE. THE FSE INSPECTED THE INSTRUMENT AND OBSERVED A SLIGHT DRIP FROM THE ASPIRATION PROBE TIP THAT INCREASED AS THE PNEUMATICS DEPLETED. THE FSE CLEANED AND EXERCISED THE SHEAR VALVES, CHECKED ASPIRATION PATHWAY AND BLOOD SAMPLING VALVE (BSV). THE FSE REMOVED, CLEANED, CHECKED PORTS AND SHAFTS OF THE BSV. THE FSE TRACED THE PATHWAY FROM THE BSV THRU SHEAR VALVES TO ASPIRATION PUMP AND REPLACED PINCH VALVES (9B AND 64), ALONG WITH ACTUATORS/TUBINGS AND CHECK VALVES. THE SYSTEM WAS TESTED MULTIPLE TIMES DURING THE TROUBLESHOOTING. THE FSE RAN SHUTDOWN, WAITED FOR THE PNEUMATICS TO TIMEOUT WITH NO FURTHER LEAK OBSERVED. A STARTUP AND CONTROLS PASSED WITHIN SPECIFICATIONS. FAILURE MODE WAS ATTRIBUTED TO PARTS AND/OR ADJUSTMENTS MADE TO THE BSV AND THE ASPIRATION PATHWAY DURING INSTRUMENT SERVICING. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BECKMAN COULTER (BEC) THAT A PUDDLE OF LH SERIES DILUENT (1 ML) WAS OBSERVED ON THE TABLE TOP WHERE THE COULTER LH 750 HEMATOLOGY ANALYZER IS SET AFTER THE COMPRESSOR TIMED OUT. THE LEAK OCCURRED AFTER RUNNING SUCCESSFUL STARTUP AND PASSING 5 C CELL CONTROL RESULTS. NO PATIENT SAMPLES WERE AFFECTED AS NONE WERE RUN AS OF YET. THE CUSTOMER INSPECTED THE BLOOD SAMPLING VALVE (BSV) AREA, AND THEY OBSERVED A DRIP COMING FROM THE ASPIRATE PROBE OF THE BSV. THE LEAK DID NOT IMPACT ANY ELECTRICAL OR OPTICAL PERFORMANCE OF THE INSTRUMENT. THE MATERIAL SAFETY DATA SHEET (MSDS) WAS NOT REVIEWED. THERE IS AN EXPOSURE CONTROL PLAN AT THE FACILITY. THE CUSTOMER WAS WEARING A LABORATORY COAT, GLOVES AND FACE SHIELD WHEN THE LEAK OCCURRED. THERE WAS NO BIOHAZARD EXPOSURE TO OPEN WOUNDS OR MUCOUS MEMBRANES. NO ONE SOUGHT MEDICAL ATTENTION. THERE WAS NO DEATH OR INJURY RESULTING FROM THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224554 COULTER® LH 750 HEMATOLOGY ANALYXZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER LH 750 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1