BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 750 HEMATOLOGY ANALYZER

    MDR report key: 2305815 · Received October 24, 2011

    Report

    Report Number
    1061932-2011-01861
    Event Type
    Malfunction
    Date Received
    October 24, 2011
    Date of Event
    September 24, 2011
    Report Date
    September 24, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    GKZ
    PMA / PMN Number
    K011342
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WENT ON-SITE AND FOUND THAT THE DIFFERENTIAL WASTE CHAMBER TOP HAD BECOME SEPARATED FROM THE PLATE WHICH CAUSED THE CONTENTS INSIDE TO SPILL. FSE REPLACED THE CHAMBER AND VERIFIED REPAIRS PER ESTABLISHED PROCEDURES. RESULTS MET PUBLISHED PERFORMANCE SPECIFICATIONS. THE ROOT CAUSE FOR THE LEAK WAS THE DEFECTIVE DIFFERENTIAL WASTE CHAMBER TOP WHICH GOT SEPARATED FROM THE PLATE. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) REPORTING A CLENZ (CLEANER) LEAK BELOW THE COULTER LH 750 HEMATOLOGY ANALYZER. THE CUSTOMER COULD NOT LOCATE THE SOURCE OF THE LEAK. THE CUSTOMER INDICATED HEARING A LOUD POPPING NOISE AND SUBSEQUENTLY, THE INSTRUMENT WOULD NOT RUN. PER CUSTOMER, THERE WAS NO BURNING SMELL. BEC CTS (CUSTOMER TECHNICAL SUPPORT) SUSPECTED A PRESSURE LEAK. CTS RECOMMENDED THE USE OF PPE BEFORE TROUBLESHOOTING AND HAD THE CUSTOMER CHECK THE TUBING FROM THE POWER SUPPLY TO DILUTER WHICH WAS NOTED TO BE FINE. PER CUSTOMER, THE SOUND SEEMED TO BE COMING FROM THE FRONT OF THE DILUTER AND THEN CLENZ WAS FOUND TO BE LEAKING. NO INJURY OR EXPOSURE WAS REPORTED AND MEDICAL ATTENTION WAS NOT SOUGHT. NO ERRONEOUS RESULTS WERE GENERATED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1