BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM

    MDR report key: 3945535 · Received July 21, 2014

    Report

    Report Number
    1061932-2014-01667
    Event Type
    Malfunction
    Date Received
    July 21, 2014
    Date of Event
    June 29, 2014
    Report Date
    June 29, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K081930
    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

    ON (B)(4) 2014, THE FIELD SERVICE ENGINEER (FSE) EVALUATED THE INSTRUMENT AND FOUND A DRIP COMING FROM THE BLEACH PROBE. THE FSE FLUSHED THE BLEACH SYSTEM TO THE RBC (RED BLOOD CELL)/WBC (WHITE BLOOD CELL) BATHS AND THE INSTRUMENT RAN WITHOUT LEAKS. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A FLUID LEAK WHEN USING THE UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM. THE LEAK WAS FROM THE BLEACH PROBE INSIDE THE INSTRUMENT. THE VOLUME OF THE LEAK WAS UNKNOWN AND WAS CONTAINED WITHIN THE INSTRUMENT. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE CUSTOMER'S FACILITY TO EVALUATE THE ANALYZER. THE OPERATOR WAS WEARING PERSONAL PROTECTIVE EQUIPMENT OF LAB COAT AND GLOVES. THERE WAS NO BIOHAZARD EXPOSURE TO MUCOUS MEMBRANES OR OPEN WOUNDS. THERE WERE NO ERRONEOUS TEST RESULTS WITH THIS EVENT. THERE WAS NO DEATH, INJURY OR AFFECT TO USER OR PATIENT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    424647 UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1