BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® HMX HEMATOLOGY ANALYZER WITH AUTOLOADER

    MDR report key: 2180186 · Received July 27, 2011

    Report

    Report Number
    1061932-2011-01037
    Event Type
    Malfunction
    Date Received
    July 27, 2011
    Date of Event
    June 23, 2011
    Report Date
    June 25, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    GKZ
    PMA / PMN Number
    K010765
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLES WERE COLLECTED IN 3 ML STANDARD AND HEMAGARD TUBES. CONTROLS WERE RUN BEFORE THE INCIDENT AND WERE WITHIN QC SPECIFICATION. THE FOLLOWING MORNING THE QC WAS NOT WITHIN SPECIFICATION UNTIL THE INSTRUMENT WAS SERVICED ON (B)(4) 2011. CURRENTLY THE INSTRUMENT IS PERFORMING WITHIN QC SPECIFICATION. THE CUSTOMER DOES NOT USE THE HMX CONTROL FILES; INSTEAD, THEY RE-LABEL THE CONTROLS AND RUN THEM AS SAMPLES INTO THEIR LIS. A BEC FIELD SERVICE ENGINEER (FSE) OBSERVED THE BSV (BLOOD SAMPLING VALVE) NOT ROTATING ON RETURN STROKE AND BSV MODULE WAS INSPECTED FOR LEAKS. FSE REPLACED LOOSE TUBING AT THE BASE OF THE SHEATH TANK TO PELRIER MODULE. FSE REMOVED AND RESEATED THE HARNESS TO PUMP MODULE AND BSV MODULE TO ALL SOLENOID CONNECTIONS AND VERIFIED BSV ROTATION. ALL SOLENOIDS WERE VERIFIED AND FLUIDIC PATHWAYS WERE FLUSHED. VERIFIED PRIMARY NEEDLE VENT AND NEEDLE RINSE CYCLES WITH FULL SAMPLES AND EMPTY TUBES. FSE RE-INSPECTED INSTRUMENT AFTER CUSTOMER CALIBRATED AND RAN EIGHTY PLUS PATIENT SAMPLES, NO FURTHER ISSUES WITH NEEDLE RINSE / VENT PATHWAYS OBSERVED. FSE FOLLOWED UP WITH CUSTOMER ON (B)(4) 2011, QC WITHIN SPECIFICATIONS AND NO ISSUES WITH PATIENT RECOVERY OBSERVED. ON (B)(4) 2011 FSE RETURNED WITH REPLACEMENT PARTS AND REPLACED PUMP MODULE, BSV HARNESS AND SOLENOIDS 16-19. FSE COMPLETED PM (PREVENTATIVE MAINTENANCE). REPAIR WAS VERIFIED AND SYSTEM WAS VALIDATED. THE ROOT CAUSE CAN BE ATTRIBUTED TO THE NEEDLE VENT NOT PROPERLY VENTING SAMPLE TUBES AND RESIDUAL VENT RINSE DILUTING SAMPLES.

    Additional Manufacturer Narrative · 1

    THE CHANGES: SERIAL NUMBER (B)(4). (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) TO REPORT QC RUNNING LOW ON CBC PARAMETERS (DUE TO THE VENT LINE DILUTING SAMPLES AFTER SAMPLE ASPIRATION) AND THAT THE BSV (BLOOD SAMPLING VALVE) PROBE STOPPED MOVING. THE ERRONEOUS RESULTS WERE NOT REPORTED OUT OF THE LABORATORY; HENCE PATIENT TREATMENT WAS NOT IMPACTED BY THIS EVENT. THE INSTRUMENT WAS TAKEN OUT OF SERVICE AND NOT USED UNTIL AFTER SERVICING ON (B)(6) 2011. REVIEW OF THE PROVIDED PATIENT SUMMARY PRINTOUT SHOWED TEN PATIENT SAMPLES WERE RUN ON (B)(6) 2011 IN THE PRIMARY MODE, OF THESE, ONLY ONE SAMPLE HAD AN INSTRUMENT GENERATED - FLAG FOR WBC WHICH WAS RERUN AND SHOWED A LOWER (HGB) RESULT. INITIAL RUN FOR THIS SAMPLE WAS CONSIDERED CORRECT. ONLY RERUN SAMPLES WERE IMPACTED. NINE OF THE TEN PATIENT SAMPLES HAD NORMAL CBC RESULTS AND WERE CONSIDERED CORRECT BASED ON INFORMATION PROVIDED, THERE WAS NO DEATH OR INJURY AND PATIENT TREATMENT WAS NOT AFFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER® HMX HEMATOLOGY ANALYZER WITH AUTOLOADER AUTOMATED CELL COUNTER. GKZ BECKMAN COULTER INC. HMX AL N/A

    Patients

    Seq Age Sex Outcome Treatment
    1