BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH500

    MDR report key: 2132532 · Received June 17, 2011

    Report

    Report Number
    1061932-2011-00667
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    May 19, 2011
    Report Date
    May 19, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K042724
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON (B)(4) 2011. THE FSE INSPECTED THE INSTRUMENT AND FOUND EVIDENCE OF A LEAK AROUND THE BOTTOM OF THE DIFF MIX AND PUMP MODULES. THE FSE ALSO FOUND A FEW KINKED TUBES ON THE PUMP MODULE. THESE WERE CORRECTED AND EVERY PINCH VALVE WAS CHECKED FOR LEAKS. SAMPLES, 2 STARTUPS AND CONTROLS WERE RAN AND ALL PASSED WITH NO LEAKS. ROOT CAUSE IS MOST LIKELY ATTRIBUTED TO KINKED TUBING ON THE DIFF PUMP MODULE THAT WAS CORRECTED DURING INSTRUMENT SERVICING.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC., (BCI) STATING THAT THERE WAS A LEAK OF FLUID AND AIR ON THE COULTER LH500 ANALYZER AND THE SOURCE COULD NOT BE LOCATED. CUSTOMER DISCONTINUED PROCESSING OF SAMPLES WHEN LEAK WAS OBSERVED AND RERAN SAMPLES ON BACKUP INSTRUMENT. THE CUSTOMER WAS WEARING GLOVES AT THE TIME OF THE EVENT AND THE SMALL AMOUNT OF LIQUID WAS CLEANED UP. THERE WAS NO EXPOSURE TO MUCOUS MEMBRANES OR OPEN WOUNDS. THERE WAS NO DEATH OR INJURY REPORTED, NO ONE SOUGHT MEDICAL ATTENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER LH500 AUTOMATED DIFFERENTIAL CELL COUNTER GKZ BECKMAN COULTER, INC. LH500 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1