BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 780 HEMATOLOGY ANALYZER

    MDR report key: 3202934 · Received July 2, 2013

    Report

    Report Number
    1061932-2013-01248
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    June 10, 2013
    Report Date
    June 10, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K061616
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE ON (B)(4) 2013. THE FSE FOUND THAT THE STARTUP WAS FAILING RETICS AND DOTTING OUT ON SAMPLES AND CONTROLS. THE RETICS OUT ON STARTUP ISSUE WAS TRACED TO A TUBING LEAK AT VALVE VL95/98. THE FSE REPLACED THE TUBING TO FIX THE LEAK. UPON FURTHER INSPECTION, THE FSE INDICATED THAT RETIC CLEAR REAGENT WOULD NOT PRIME WHICH WAS CAUSED BY A SLUGGISH ACTUATOR FOR VALVE VL95/98. THE FSE REPLACED THE ACTUATOR. THE FSE RAN THE STARTUP WITH ALL PARAMETERS NOW PASSING BACKGROUNDS. THE FSE ALSO RAN SAMPLES AND NOTED THE RETICS WERE NOT GETTING RESULTS (RETIC VOTE-OUTS, NON-NUMERIC VALUES WERE GENERATED). UPON FURTHER INVESTIGATION, THE FSE DISCOVERED THAT THE RETIC SHEAR VALVE, VL99, AND THE RETIC STAIN PUMP WERE NOT WORKING. THE FSE ORDERED PARTS AND RETURNED TO THE CUSTOMER'S LABORATORY ON (B)(4) 2013 AND REPLACED MANIFOLD (MF16). THE FSE VERIFIED THE INSTRUMENT'S OPERATIONS. FAILURE MODE WAS ATTRIBUTED TO THE TUBING BEING OFF AT THE BSV, TUBING AT VL95/98, ACTUATOR FOR VL95/98, AND 3 SOLENOIDS ON MANIFOLD (MF16) NOT FIRING. HOWEVER, THE STARTUP FAILED RETIC AND THE SAMPLES GAVE NON-NUMERIC RESULTS FOR THE RETIC PARAMETER ALERTING THE CUSTOMER TO AN INSTRUMENT PROBLEM AND TO REVIEW RESULTS. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BECKMAN COULTER (BEC) STATING THAT WHILE RUNNING A STARTUP THIS MORNING ON THE COULTER LH 780 HEMATOLOGY ANALYZER, THE RETICS FAILED. PER CUSTOMER, WHEN THEY OPENED THE FRONT COVER THEY NOTICED A TUBING BEING OFF ON THE BLOOD SAMPLING VALVE (BSV). THE CUSTOMER INDICATED THAT THE LEAK WAS ABOUT 5 ML OF THE BLUE CLEANER SOLUTION BELOW THE BSV AREA AND WAS CONTAINED WITHIN THE INSTRUMENT. THE CUSTOMER STATED THAT THEY RE-ATTACHED THE TUBING AND CLEANED UP THE LEAK PER THE LABORATORY'S PROTOCOL. THE CUSTOMER REPEATED THE STARTUP SEVERAL TIMES BUT WAS FAILING THE RETIC BACKGROUND, AND THEY STOPPED USING THE INSTRUMENT AT THIS TIME AND CALLED FOR SERVICE. THE MATERIAL SAFETY DATA SHEET (MSDS) WAS NOT REVIEWED BY THE CUSTOMER. THE LABORATORY¿S EXPOSURE CONTROL/RISK MANAGEMENT PLANS ARE IN PLACE. THE CUSTOMER WAS WEARING GLOVES, A LABORATORY COAT AND PROTECTIVE EYE WEAR AT THE TIME OF THE EVENT. NO ONE CAME INTO DIRECT CONTACT WITH THE LEAK. THERE WAS NO BIOHAZARD EXPOSURE TO OPEN WOUNDS OR MUCOUS MEMBRANES. MEDICAL ATTENTION WAS NOT SOUGHT. NO PATIENT RESULTS WERE AFFECTED AND NO ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY. THERE WAS NO CHANGE TO PATIENT TREATMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302392 COULTER® LH 780 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER LH780 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1