BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BECKMAN COULTER ¿ COULTER ® LH 750 HEMATOLOGY ANALYZER

    MDR report key: 2242294 · Received September 10, 2011

    Report

    Report Number
    1061932-2011-01435
    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
    K011342
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2011, A BEC FIELD SERVICE ENGINEER (FSE) FOUND A LEAK AT THE LEE VALVE OF THE SLIDE MAKER ASPIRATION AREA. FSE REPLACED THE TUBING AND ALL REPAIRS WERE VERIFIED PER ESTABLISHED PROCEDURES. FSE INDICATED THAT THE LEAK WAS DUE TO A SPLIT IN THE DURO TUBING RUNNING THROUGH VL1 IN THE SLIDE MAKER ASPIRATION AREA. THE TUBING WAS SPLIT GOING THROUGH THE VALVE, DUE TO WEAR CAUSED BY NORMAL OPERATION. THE FSE ALSO STATED THAT ONLY DILUENT AND BLOOD LEAKED. ROOT CAUSE FOR THE LEAK IS THAT THE TUBING GOING THROUGH VL1 WAS SPLIT DUE TO WEAR. BEC INTERNAL IDENTIFICATION NUMBER IS (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BECKMAN COULTER INC (BEC) TO REPORT A LEAK AT THE SAMPLE ACCESS MODULE OF THE BECKMAN COULTER - COULTER LH 750 HEMATOLOGY ANALYZER. PER CUSTOMER, THE LEAK APPEARED TO BE BLOOD AND ISOTON. THE USER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF GLOVES LAB COAT AND GLASSES AT THE TIME OF THE INCIDENT. THE MSDS WAS NOT REVIEWED, HOWEVER IT IS READILY AVAILABLE. MEDICAL ATTENTION WAS NOT SOUGHT. 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 COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BECKMAN COULTER ¿ COULTER ® LH 750 HEMATOLOGY ANALYZER AUTOMATED DIFFERENTIAL CELL COUNTER GKZ BECKMAN COULTER INC. LH750 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1