BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 780 HEMATOLOGY ANALYZER

    MDR report key: 2242258 · Received September 10, 2011

    Report

    Report Number
    1061932-2011-01438
    Event Type
    Malfunction
    Date Received
    September 10, 2011
    Date of Event
    August 11, 2011
    Report Date
    August 11, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    GKZ
    PMA / PMN Number
    K061616
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2011, A BEC FIELD SERVICE ENGINEER (FSE) OBSERVED THAT THE SOURCE OF THE LEAK WAS A CUT IN THE TUBING AT PINCH VALVE 59 (BACKWASH DISABLE). FSE REPLACED THE CUT TUBING. NO FURTHER EVIDENCE OF LEAKING OCCURRED. ROOT CAUSE OF THE LEAK WAS A CUT TUBING IN PINCH VALVE 59. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BECKMAN COULTER INC (BEC) TO REPORT SMALL CLENZ LEAK UNDERNEATH THE BLOOD SAMPLING VALVE (BSV) OF THE COULTER LH 780 HEMATOLOGY ANALYZER. THE USER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF GOWN, GLOVES AND GOGGLES AT THE TIME OF THE INCIDENT. NO INJURY OR EXPOSURE TO THE FLUID WAS REPORTED. MEDICAL ATTENTION WAS NOT SOUGHT. NO REPORT OF EXPOSURE TO MUCOUS MEMBRANES OR OPEN WOUNDS. THE MATERIAL SAFETY DATA SHEET (MSDS) WAS NOT REVIEWED; HOWEVER, IT IS READILY AVAILABLE. THE INSTRUMENT WAS NOT IN USE AT THE TIME OF THE EVENT; THEREFORE THERE WAS NO IMPACT TO PATIENT RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER LH 780 HEMATOLOGY ANALYZER AUTOMATED DIFFERENTIAL CELL COUNTER GKZ BECKMAN COULTER INC. LH780 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1