BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 780 HEMATOLOGY ANALYZER

    MDR report key: 3920378 · Received July 8, 2014

    Report

    Report Number
    1061932-2014-01551
    Event Type
    Malfunction
    Date Received
    July 8, 2014
    Date of Event
    June 17, 2014
    Report Date
    June 17, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K061616
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2014, A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) EVALUATED THE INSTRUMENT AND CONFIRMED THE LEAK FROM THE DISCONNECTED FLOW CELL SAMPLE LINE TUBING FROM THE BOTTOM OF THE MIXING CHAMBER (VC25) TO THE FLOW CELL (VC18). THE FSE REPLACED THE SAMPLE LINE TUBING AND REINFORCED IT WITH A SLEEVE RESOLVING THE LEAK. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED A LEAK WHEN USING THE COULTER LH 780 HEMATOLOGY ANALYZER. THERE WAS A LEAK OF AN UNKNOWN AMOUNT OF BLOODY FLUID COMING FROM THE RIGHT HAND SIDE OF THE INSTRUMENT. THE LEAK WAS CONTAINED WITHIN THE INSTRUMENT. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE CUSTOMER'S FACILITY TO EVALUATE THE INSTRUMENT. THE OPERATOR WAS WEARING A LAB COAT AND GLOVES AT THE TIME OF THE INCIDENT. THERE WAS NO REPORT OF BIOHAZARD EXPOSURE TO MUCOUS MEMBRANES OR OPEN WOUNDS. THERE WAS NO REPORT OF ERRONEOUS TEST RESULTS ASSOCIATED WITH THIS EVENT. THERE WAS NO DEATH, INJURY OR AFFECT TO PATIENT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    397616 COULTER LH 780 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1