BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® HMX HEMATOLOGY ANALYZER WITH AUTOLOADER

    MDR report key: 2832802 · Received November 14, 2012

    Report

    Report Number
    1061932-2012-02668
    Event Type
    Malfunction
    Date Received
    November 14, 2012
    Date of Event
    October 22, 2012
    Report Date
    October 22, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K010765
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PV21, NORMAL STATE: OPENS PATH FROM NEEDLE BELLOWS TO WASTE, VENT WASTE CHAMBER (VC3). IN OPERATED STATE: OPENS DRAIN PATH FROM VC3 TO VC7. PV49, NORMAL STATE: PROVIDES OPEN PATH FOR VACUUM AND DILUENT TO PM8. PROVIDES OPEN VACUUM PATH FROM PROBE WIPER TO VC7 VIA VL35. IN OPERATED STATE: OPENS PATH FOR 30-PSI PRESSURE TO PM8. OPENS DILUENT PATH FOR NEEDLE BACKWASH. PV40 PROVIDES OPEN DRAIN PATH FROM DIFF WASTE CHAMBER (VC7) TO WASTE CHAMBER (VC1). (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED APPROXIMATELY 3 ML OF UNCONTAINED DILUENT/BLOOD LEAK ON THE COULTER HMX HEMATOLOGY ANALYZER WITH AUTOLOADER AT THE PROBE WASH. THE FLUIDS ASSOCIATED WITH THE LEAK ARE BLOOD, DILUENT AND CLENZ. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT CONSISTING OF GLOVES AND LABORATORY COAT WHEN THE LEAK WAS FOUND. THE CUSTOMER DID NOT COME IN CONTACT WITH THE FLUID AND DID NOT SEEK MEDICAL ATTENTION. NO EXPOSURE (SPRAYED OR SPLASHED) TO MUCOUS MEMBRANES OR OPEN WOUNDS WERE REPORTED. NO DEATH, INJURY OR CHANGES TO PATIENT TREATMENT OR RESULTS ARE ASSOCIATED WITH THIS EVENT. THE CUSTOMER DID NOT REVIEW THE MSDS; HOWEVER, THE FACILITY DOES HAVE A RISK MANAGEMENT / EXPOSURE CONTROL PLAN IS IN PLACE. ON THE DAY OF THE EVENT ((B)(6) 2012) A FIELD SERVICE ENGINEER (FSE) WAS ON SITE AND ADJUSTED THE RINSE BLOCK AND REPLACED ALL TUBING THROUGH PV21, 49 AND 40, WHICH RESOLVED THE LEAK. THE FAILURE MODE OF THE LEAK WAS ATTRIBUTED TO PARTS REPLACED BY THE FSE DURING INSTRUMENT SERVICE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1