BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 500 HEMATOLOGY ANALYZER

    MDR report key: 3072041 · Received April 22, 2013

    Report

    Report Number
    1061932-2013-00709
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Date of Event
    March 25, 2013
    Report Date
    March 25, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K042724
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) OBSERVED CLEAR FLUID LEAKED FOLLOWING THE NEEDLE BACKWASH DUE TO SLOW DRAIN OF THE BELLOWS DURING THE BACKWASH CYCLE. THE FSE REPLACED THE ACTUATOR FOR PINCH VALVES PV21 AND PV22 AND RESOLVED THE FLUID LEAK ISSUE. THE FSE FURTHER DISCOVERED A BLOCKED VACUUM RESTRICTOR TUBING TO LINE FMT1. THE FSE REPLACED THE TUBING AND PERFORMED MULTIPLE CYCLES WITH NO FURTHER EVIDENCE OF FLUID LEAK. THE FSE DETERMINED THE ACTUATOR AND THE BLOCKED SAMPLE TUBING CONTRIBUTED TO THE FLUID LEAK AND RELATED SYSTEM ERROR MESSAGES. THE FSE REPORTED THE HEMOGLOBIN AND HEMATOCRIT (H&H) CHECK FAILURES WERE UNRELATED TO THE FLUID LEAK AND NOTED QUALITY CONTROL LEVELS SHOWED INCREASES IN RBCS AND MCVS ON ALL THREE QUALITY CONTROL LEVELS. THE FSE ADJUSTED THE CALIBRATION FACTORS FOR THE RED BLOOD CELL (RBC) AND MEAN CELL VOLUME (MCV) THEN PERFORMED SUCCESSFUL REPRODUCIBILITY TESTS TO RESOLVE THE H&H ISSUES. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED APPROXIMATELY TWO MILLILITERS OF FLUID LEAKED OUTSIDE THE INSTRUMENT AND ONTO THE COUNTER INVOLVING THE COULTER LH 500 HEMATOLOGY ANALYZER. THE OPERATOR WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF GLOVES AND A LABORATORY COAT AND DID NOT HAVE DIRECT CONTACT WITH THE FLUID. THERE WAS NO OPERATOR INJURY OR ADVERSE EFFECT ASSOCIATED WITH THIS EVENT. THE CUSTOMER STATED ASPIRATION P ERRORS, WITH SOME H&H FAILURES, WERE OBTAINED ON CONTROLS DURING THE FLUID LEAK. PATIENT SAMPLES WERE NOT ANALYZED AT THE TIME OF THE EVENT. PATIENT RESULTS WERE NOT IMPACTED. THERE WAS NO PATIENT CONSEQUENCE. ALL PATIENT SPECIMENS WERE SENT TO A REFERENCE LABORATORY FOR ANALYSIS; RESULTS OBTAINED WERE NOT RELEASED FROM THE LABORATORY. THE LABORATORY HAS AN EXPOSURE CONTROL/RISK MANAGEMENT PLAN IN PLACE. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172528 COULTER® LH 500 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1