BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 500 HEMATOLOGY ANALYZER

    MDR report key: 3103433 · Received May 9, 2013

    Report

    Report Number
    1061932-2013-00772
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Date of Event
    April 15, 2013
    Report Date
    April 15, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K032000
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BECKMAN COULTER (BEC) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE ON (B)(4) 2013. THE FSE INSPECTED THE INSTRUMENT AND WAS ABLE TO CONFIRM A LEAK AT THE NEEDLE LOCATION. THE FSE DISCOVERED THAT THE NEEDLE BELLOWS WAS NOT DRAINING PROPERLY AND CAUSING BLOODY DILUENT TO OVERFLOW OUT OF THE TOP OF THE NEEDLE BELLOWS ASSEMBLY. THE FSE PERFORMED A BLEACH PROCEDURE ON THE NEEDLE BELLOWS DRAIN PATHWAY AND REMOVED A CLOT FROM THE PATHWAY. FAILURE MODE WAS A CLOT IN THE NEEDLE BELLOWS ASPIRATION/DRAIN PATHWAY. HOWEVER, THE INSTRUMENT PROVIDED ASPIRATION ERRORS AND/OR NO CONTROL RESULTS TO ALERT THE OPERATOR TO AN INSTRUMENT PROBLEM. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BECKMAN COULTER (BEC) AND STATED THAT THERE WAS A BLOODY FLUID LEAK (1CC) UNDER THE ROCKERBED NEAR THE NEEDLE CARTRIDGE, WHEN PERFORMING MORNING START-UP ON THE COULTER LH 500 HEMATOLOGY ANALYZER. PARTIAL ASPIRATIONS ERRORS AND NO RESULTS WERE OCCURRING ON CONTROLS. THE LEAK WAS CONTAINED WITHIN THE INSTRUMENT. THE MATERIAL SAFETY DATA SHEET (MSDS) WAS NOT REVIEWED. THERE IS AN EXPOSURE CONTROL PLAN AT THE FACILITY. THE OPERATOR WAS WEARING A LABORATORY COAT, GLOVES AND FACE PROTECTION. THERE WAS NO BIOHAZARD EXPOSURE TO OPEN WOUNDS OR MUCOUS MEMBRANES. NO ONE SOUGHT MEDICAL ATTENTION. NO PATIENT RESULTS WERE RUN AS THE CUSTOMER COULD NOT GET CONTROLS TO RUN. NO PATIENT RESULTS WERE AFFECTED. THERE WAS NO DEATH, INJURY OR EFFECT TO PATIENT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203302 COULTER® LH 500 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER LH 500 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1