BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® HMX HEMATOLOGY ANALYZER WITH AUTOLOADER

    MDR report key: 3241540 · Received July 22, 2013

    Report

    Report Number
    1061932-2013-01418
    Event Type
    Malfunction
    Date Received
    July 22, 2013
    Date of Event
    June 24, 2013
    Report Date
    June 24, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K010765
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PER CUSTOMER TECHNICAL SERVICE (CTS), PRIOR TO CALLING THE HOTLINE, THE CUSTOMER HAD ALREADY FLUSHED, BLEACHED, DRAINED AND VENTED AND SAW NO OBVIOUS PROBLEMS. THE CTS HAD THE CUSTOMER PERFORM A SYSTEM TEST AND ALL PARAMETERS PASSED WITH NO ISSUES. BECKMAN COULTER (BEC) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE ON (B)(4) 2013 TO EVALUATE THE INSTRUMENT. THE FSE VERIFIED THAT THE ANALYZER WAS RECOVERING LOW ON CONTROLS SEVERAL DAYS AFTER PM (PREVENTATIVE MAINTENANCE). THE FSE RAN REPRODUCIBILITY PROCEDURES AND FOUND THAT THE RESULTS WERE STEADILY DECREASING. UPON FURTHER INVESTIGATION, THE FSE DETERMINED THAT SAMPLES WERE NOT GETTING VENTED AND THE UNIT WAS DILUTING THE SAMPLES WITH DILUENT. THE FSE LEFT ON (B)(4) 2013 ASKING THE CUSTOMER TO MONITOR THE INSTRUMENT AFTER FINDING THE VENT LINE WAS GETTING PINCHED ON THE PUMP MODULE AND ADDITIONAL SERVICE WAS NEEDED. THE FSE RETURNED TO THE CUSTOMER'S LABORATORY ON (B)(4) 2013 TO COMPLETE THE SERVICE. THE FSE STATED THAT THE PINCHED WENT LINE WAS CORRECTED. PER THE FSE, A SET OF WORN SOLENOIDS 30-25, ASSOCIATED WITH VENT/PRIMARY ASPIRATION PATHWAY ON THE PUMP MODULE, WAS ALSO REPLACED ON A RETURN VISIT. FOLLOWING THE PARTS REPLACEMENT, THE FSE RAN SEVERAL REPRODUCIBILITY PROCEDURES, CONTROLS, AND PATIENT SAMPLES WITH NO OTHER ISSUES IDENTIFIED. PER CONVERSATION WITH THE FSE ON (B)(4) 2013, THE INSTRUMENT WAS OPERATIONAL WITH NO FURTHER ISSUES. FAILURE MODE WAS ATTRIBUTED TO THE PINCHED VENT LINE. ADDITIONALLY, WORN SET OF SOLENOIDS ON THE PUMP MODULE WAS ADDRESSED BY THE FSE. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER CALLED IN ON (B)(6) 2013 REPORTING THAT 5C CONTROLS SUDDENLY DROPPED OUT OF SPECIFICATIONS ON THE COULTER HMX HEMATOLOGY ANALYZER WITH AUTOLOADER. WHEN CUSTOMER CONTACT WAS FIRST MADE ON (B)(6) 2013, THE DILUTION ISSUE WAS IDENTIFIED AS ONLY OCCURRING WITH CONTROLS AND THE INITIAL INFORMATION PROVIDED TO THE FIELD SERVICE ENGINEER (FSE) WAS THAT NO PATIENT RESULTS WERE IMPACTED, THEREFORE NO EFFECT TO PATIENT TREATMENT WAS REPORTED IN RELATION TO THIS EVENT. THIS MDR IS TO REPORT THE QUALITY CONTROL (QC) ISSUE OCCURRED ON (B)(6) 2013. AN MDR 1061932-2013-01551 IS BEING SUBMITTED FOR THE EVENT OCCURRED ON (B)(6) 2013, AFFECTING PATIENT RESULTS, AT THIS CUSTOMER SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340629 COULTER® HMX HEMATOLOGY ANALYZER WITH AUTOLOADER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER HMX AL N/A

    Patients

    Seq Age Sex Outcome Treatment
    1