BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 750 HEMATOLOGY ANALYZER.

    MDR report key: 3260560 · Received August 1, 2013

    Report

    Report Number
    1061932-2013-01623
    Event Type
    Malfunction
    Date Received
    August 1, 2013
    Date of Event
    July 16, 2013
    Report Date
    July 16, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K011342
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER'S SITE. THE FSE DISCOVERED A DISCONNECTED UPPER SHEATH TUBING ON THE RIGHT SIDE OF THE INSTRUMENT. THE FSE REPLACED ALL UPPER SHEATH TUBING TO RESOLVE THE LEAK AND DRIED OUT CONNECTORS TO SENSOR DISTRIBUTION BOARD TO RESOLVE THE ERRORS. FAILURE MODE OF THE LEAK IS ATTRIBUTED TO A DISCONNECTED UPPER SHEATH TUBING ON THE RIGHT SIDE OF THE INSTRUMENT; THE INSTRUMENT GENERATED PROBE OBSTRUCTION, BELLOWS NOT UP, AND BACKWASH TANK NOT FULL ERRORS TO ALERT THE OPERATOR TO AN INSTRUMENT PROBLEM. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED OBTAINING PROBE OBSTRUCTION, BELLOWS NOT UP, AND BACKWASH TANK NOT FULL ERRORS FROM THE COULTER LH 750 HEMATOLOGY ANALYZER. THE CUSTOMER ATTEMPTED TO REPLACE THE PROBE BUT THE INSTRUMENT WAS STILL GENERATING THE PROBE OBSTRUCTION ERROR. THE CUSTOMER STATED THAT THE DIFF PAK REAGENT WAS EMPTY BUT THE INSTRUMENT DID NOT PROMPT THE CUSTOMER TO CHANGE THE REAGENT. THE CUSTOMER THEN DISCOVERED APPROXIMATELY 3 ML OF CLEAR FLUID LEAK FROM THE INSTRUMENT. THE CUSTOMER INDICATED THAT THE LEAK WAS NOT CONTAINED WITHIN THE INSTRUMENT. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT CONSISTING OF A LABORATORY COAT AND GLOVES AT THE TIME OF THE EVENT AND NO INJURY OR EXPOSURE WAS REPORTED. NO ERRONEOUS PATIENT RESULTS WERE GENERATED AND THERE WAS NO CHANGE OR AFFECT TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359457 COULTER® LH 750 HEMATOLOGY ANALYZER. COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1