BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER HMX HEMATOLOGY ANALYZER WITH AUTOLOADER

    MDR report key: 3852387 · Received June 5, 2014

    Report

    Report Number
    1061932-2014-01219
    Event Type
    Malfunction
    Date Received
    June 5, 2014
    Date of Event
    May 8, 2014
    Report Date
    May 8, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K010765
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER (BEC) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ASSESS THE INSTRUMENT. THE FSE FOUND THE RED BLOOD CELL (RBC) AND WHITE BLOOD CELL (WBC) BATHS WERE NOT FILLING PROPERLY AS A RESULT OF THE BLOOD SAMPLING VALVE (BSV) NOT ALIGNING PROPERLY. THE MISALIGNMENT WAS CAUSING THE LEAK AND THE IMPROPER DILUTION OF THE SAMPLE. THE FSE REPLACED THE BSV AND BSV ACTUATOR WHICH RESOLVED THE DROP IN RECOVERY OF THE WBC AND RBC ISSUE BUT THIS DID NOT RESOLVE THE LEAK ISSUE. FURTHER INVESTIGATION REVEALED THE PROBE RINSE BLOCK ASSEMBLY WAS NOT MOVING TO THE PROPER LOCATION. THE FSE REPLACED THE PROBE RINSE BLOCK ASSEMBLY TO RESOLVE THE LEAK REPORTED. THE INSTRUMENT WAS RETURNED TO NORMAL OPERATION. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE DROP IN THE RECOVERY OF THE WHITE BLOOD CELL (WBC) AND RED BLOOD CELL (RBC) COUNT WHILE RUNNING QUALITY CONTROLS (QC); AND A LEAK OF LESS THAN 10 ML OF FLUID FROM THE SECONDARY PROBE OF THE COULTER HMX HEMATOLOGY ANALYZER WITH AUTOLOADER. THE LEAK WAS NOT CONTAINED WITHIN THE INSTRUMENT. THE CUSTOMER WAS WEARING GLOVES, GOGGLES AND LAB COAT AT THE TIME OF THE INCIDENT. THERE WAS NO EXPOSURE TO OPEN WOUNDS OR MUCOUS MEMBRANES. NO ERRONEOUS RESULTS WERE GENERATED IN CONNECTION WITH THE REPORTED EVENT. THERE WAS NO DEATH, INJURY, OF AFFECT TO USER OR TO PATIENT TREATMENT ATTRIBUTED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328909 COULTER HMX HEMATOLOGY ANALYZER WITH AUTOLOADER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1