BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 500 HEMATOLOGY ANALYZER

    MDR report key: 2873171 · Received December 13, 2012

    Report

    Report Number
    1061932-2012-02827
    Event Type
    Malfunction
    Date Received
    December 13, 2012
    Date of Event
    November 17, 2012
    Report Date
    November 17, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K042724
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER TECHNICAL SUPPORT (CTS) GUIDED THE CUSTOMER TO IDENTIFY AND TROUBLESHOOT THE ISSUE DURING THE INITIAL INTAKE CALL. THE CUSTOMER IDENTIFIED A BROKEN PINCH VALVE 49 AS THE SOURCE OF THE LEAK. THE CUSTOMER REMOVED AND REPLACED THE BROKEN PINCH VALVE 49 AND ASSOCIATED TUBING WITH GUIDANCE FROM CTS. THE CUSTOMER THEN VERIFIED THE SYSTEM PERFORMANCE THROUGH QUALITY CONTROLS; ALL QUALITY CONTROLS WERE WITHIN SPECIFICATION. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BECKMAN COULTER INC THAT THE COULTER LH 500 HEMATOLOGY ANALYZER WAS LEAKING. THE CUSTOMER OPINES THE LEAK TO BE IN THE TUBING FROM FEED THROUGH FITTINGS FF183 TO FF173. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT AT THE TIME THE EVENT WAS NOTED. APPROXIMATELY 50CC OF FLUID LEAKED AND WAS NOT CONTAINED WITHIN THE INSTRUMENT. THERE WERE NO INJURIES OR EXPOSURES TO ANY LABORATORY PERSONNEL. NO PATIENT RESULTS WERE AFFECTED. QUALITY CONTROLS WERE WITHIN RANGE. BECKMAN COULTER FIELD SERVICE WAS NOT DISPATCHED TO THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER® LH 500 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL, GKZ BECKMAN COULTER, INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1