BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 750 HEMATOLOGY ANALYZER

    MDR report key: 3241780 · Received July 22, 2013

    Report

    Report Number
    1061932-2013-01568
    Event Type
    Malfunction
    Date Received
    July 22, 2013
    Date of Event
    June 27, 2013
    Report Date
    June 27, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K061574
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER RE-ATTACHED THE TUBING THAT HAD POPPED OFF THE BLOOD SAMPLING VALVE (BSV). THE CUSTOMER INDICATED THAT THE LEAK WAS STILL PRESENT. A BEC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE INSTRUMENT. THE FSE REROUTED THE TUBING ON THE BSV TO GIVE IT MORE PLAY DURING THE ROTATION OF THE BSV. THE FSE ALSO TIGHTENED THE PROBE WIPE WASTE TRUCK WHICH WAS LOOSE. THE FSE VERIFIED THE INSTRUMENT WITH NO FURTHER LEAKS OBSERVED. PER LABELING, BECKMAN COULTER URGES ITS CUSTOMERS TO COMPLY WITH ALL NATIONAL HEALTH AND SAFETY STANDARDS SUCH AS THE USE OF BARRIER PROTECTION. THIS MAY INCLUDE, BUT IT IS NOT LIMITED TO, PROTECTIVE EYEWEAR, GLOVES, AND SUITABLE LABORATORY ATTIRE WHEN OPERATING OR MAINTAINING THIS OR ANY OTHER AUTOMATED LABORATORY ANALYZER. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER (BEC) REPORTING 50 CUBIC CENTIMETERS (CCS) OF DILUENT THAT LEAKED ONTO THE COUNTER TOP FROM THE COULTER LH 750 HEMATOLOGY ANALYZER. THE CUSTOMER STATED THAT THEY HAD ALREADY PERFORMED STARTUP, CONTROLS, AND RUN ABOUT FIFTEEN (15) PATIENT SAMPLES FOR THE DAY WHEN THE LEAK WAS NOTICED. THE CUSTOMER OPENED THE FRONT OF THE INSTRUMENT AND FOUND THAT THE LEAK WAS COMING FROM THE TUBING THAT HAD POPPED OFF OF THE BLOOD SAMPLING VALVE (BSV). THE OPERATOR WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF GLOVES AND A LABORATORY COAT AT THE TIME OF THE EVENT. THE MATERIAL SAFETY DATA SHEET (MSDS) WAS NOT REVIEWED. THE LABORATORY'S EXPOSURE CONTROL/RISK MANAGEMENT PLANS ARE IN PLACE. THERE WAS NO BIOHAZARD EXPOSURE TO MUCOUS MEMBRANES OR OPEN WOUNDS. THE OPERATOR DID NOT SEEK MEDICAL ATTENTION. THE CUSTOMER INDICATED THAT NO ERRONEOUS RESULTS HAD BEEN REPORTED OUT OF THE LABORATORY WHEN THE LEAK WAS NOTICED. THE CUSTOMER STATED THAT ALL SAMPLES RAN ON THE DAY OF THE EVENT WILL BE RE-RUN ON AN ALTERNATE INSTRUMENT TO CONFIRM THAT NO ERRONEOUS RESULTS WERE GENERATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340735 COULTER® LH 750 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER LH 750 NA

    Patients

    Seq Age Sex Outcome Treatment
    1