BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 780 HEMATOLOGY ANALYZER

    MDR report key: 2242197 · Received September 9, 2011

    Report

    Report Number
    1061932-2011-01341
    Event Type
    Malfunction
    Date Received
    September 9, 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
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2011, A BEC FIELD SERVICE ENGINEER (FSE) REPLACED THE TUBING AND CHECK VALVES GOING FROM THE NEEDLE DRAIN TO THE WASTE CHAMBER. THE LEAK OBSERVED BY THE FSE WAS A MIXTURE OF BLOOD, CLENZ AND DILUENT. A BEC FIELD SERVICE ENGINEER (FSE) INDICATED THAT THE LEAK WAS DUE TO A PLUG IN THE WASTE PATHWAY FROM THE PIERCE NEEDLE BELLOWS. THE BELLOWS OVERFLOWED ON BACKWASH. THE PLUG WAS CLEARED BY REPLACING ALL TUBING AND 2 CHECK VALVES IN THE BELLOWS DRAIN PATHWAY. ROOT CAUSE FOR THE LEAK WAS A PLUG IN THE WASTE PATHWAY FROM THE PIERCE NEEDLE BELLOWS CAUSING THEM TO OVERFLOW. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BECKMAN COULTER INC (BEC) TO REPORT BLOOD LEAK FROM THE TOP OF THE NEEDLE CARTRIDGE 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. THE MSDS WAS NOT REVIEWED, HOWEVER IT IS READILY AVAILABLE. MEDICAL ATTENTION WAS NOT SOUGHT. THERE WAS NO REPORT OF EXPOSURE TO MUCOUS MEMBRANES OR OPEN WOUNDS. THE LAB'S EXPOSURE CONTROL OR RISK MANAGEMENT PLANS ARE IN PLACE. NO DEATH, INJURY OR CHANGE TO PATIENT TREATMENT ATTRIBUTED OR ASSOCIATED TO THIS EVENT.

    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