BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 750 HEMATOLOGY ANALYZER

    MDR report key: 3203180 · Received July 2, 2013

    Report

    Report Number
    1061932-2013-01356
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    June 4, 2013
    Report Date
    June 4, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K061574
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BEC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON (B)(4) 2013 TO EVALUATE THE INSTRUMENT. THE FSE REPLACED A BENT NEEDLE FROM THE CUSTOMER'S STOCK, CLEANED THE BLOOD SAMPLING VALVE (BSV), AND THE SHEAR VALVES. THE FSE VERIFIED UNIT OPERATION WITH NO FURTHER LEAKS DETECTED. FAILURE MODE: BENT NEEDLE, DIRTY BSV AND SHEAR VALVES. HOWEVER, AN ASPIRATION ERROR WAS PROVIDED FOR THIS EVENT TO ALERT THE OPERATOR TO AN INSTRUMENT PROBLEM. 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 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

    THE CUSTOMER CONTACTED BECKMAN COULTER (BEC) REPORTING A BLOOD LEAK IN THE PRIMARY MODE AREA OF THE COULTER LH 750 HEMATOLOGY ANALYZER. THE LEAK WAS CONTAINED WITHIN THE INSTRUMENT. THE CUSTOMER INDICATED THAT ASPIRATION B ERRORS WERE ALSO GENERATED DURING THIS EVENT. THE OPERATOR WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE); HOWEVER, THE SPECIFIC PPE WAS NOT PROVIDED. 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. MEDICAL ATTENTION WAS NOT SOUGHT. NO ERRONEOUS RESULTS WERE GENERATED IN CONNECTION TO THE REPORTED EVENT. THE INSTRUMENT WAS NOT USED AFTER EXPERIENCING THE ERRORS. PATIENT SPECIMENS WERE PROCESSED ON ANOTHER ANALYZER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301227 COULTER® LH 750 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER LH 750 NA

    Patients

    Seq Age Sex Outcome Treatment
    1