BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 750 HEMATOLOGY ANALYXZER

    MDR report key: 3071948 · Received April 22, 2013

    Report

    Report Number
    1061932-2013-00630
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Date of Event
    March 27, 2013
    Report Date
    March 27, 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
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE. THE FSE FOUND CUT TUBING ABOVE THE WHITE BLOOD CELL (WBC) BATH AND REPLACED THE TUBING. THE FSE NOTICED SMALL BUBBLES IN THE WBC DILUENT DISPENSE PUMP AND REPLACED THE DILUENT DISPENSE PUMP. THE FSE INDICATED THE INSTRUMENT WAS HAVING ISSUES WITH THE H&H. THE FSE REPLACED HEMOGLOBIN (HGB) CHAMBER AND ALL TUBING GOING TO AND FROM THE HGB CHAMBER. PER THE FSE, LATRON WAS ALSO GIVING HIGH VOLUME AND CONDUCTIVITY COUNTS AND LOW DIFFERENTIAL AND RETIC SCATTER. THE FSE REPLACED ALL SAMPLE LINES GOING TO THE FLOW CELL THAT WERE DISCOLORED AND POSSIBLY CLOGGED. THE FSE PRIMED ALL LINES THAT WERE REPLACED, ADJUSTED THE VOLUME, CONDUCTIVITY, DIFFERENTIAL SCATTER, AND RETIC SCATTER THAT FIXED THE LEAK; CONDUCTIVITY COUNTS AND LOW DIFFERENTIAL AND RETIC SCATTER. FAILURE MODE WAS CUT TUBING AT WBC BATH, WBC DILUENTS DISPENSE PUMP PROBLEMS, LOW DIFFERENTIAL AND RETIC SCATTER AND PROBLEMS WITH SAMPLE LINES TO FLOW CELL. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BECKMAN COULTER THAT THE COULTER LH 750 HEMATOLOGY ANALYZER WAS LEAKING DILUENT BEHIND THE WHITE BLOOD CELL (WBC) BATH. THE VOLUME OF THE LEAKED FLUID WAS 5 CC AND THE LEAK WAS CONTAINED WITHIN THE INSTRUMENT. THE MATERIAL SAFETY DATA SHEET (MSDS) WAS REVIEWED. THERE IS AN EXPOSURE CONTROL PLAN AT THE FACILITY. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE), INCLUDING GLOVES, GOWN AND GOGGLES. NO ONE WAS SPLASHED, SPRAYED OR INJURED. THERE WAS NO CONTACT TO OPEN OR BROKEN SKIN OR MUCOUS MEMBRANES. NO ONE SOUGHT MEDICAL ATTENTION. THE LEAK OCCURRED WHEN THE CUSTOMER WAS RUNNING THE LATRON QUALITY CONTROL (QC); NO SAMPLES WERE RUN ON THE INSTRUMENT.THERE WAS NO DEATH, INJURY OR AFFECT TO PATIENT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172251 COULTER® LH 750 HEMATOLOGY ANALYXZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER LH 750 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1