BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 750

    MDR report key: 2082335 · Received May 9, 2011

    Report

    Report Number
    1061932-2011-00395
    Event Type
    Malfunction
    Date Received
    May 9, 2011
    Date of Event
    April 11, 2011
    Report Date
    April 11, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K011342
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SPILL WAS CLEANED UP ACCORDING TO THE DEFINED LABORATORY PROTOCOL. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON (B)(4) 2011. PER FSE, THE TUBING WAS OFF ON SLIDE MAKER PROBE THEREFORE THE BLOOD LEAKED OUT ON THE UNIT RATHER THAN THE SLIDE. THE TUBING WAS CUT AND REATTACHED. RACKS SLIDES WERE MADE AND REPAIRS PER ESTABLISHED PROCEDURES WERE VERIFIED AND RESULTS MEET PUBLISHED PERFORMANCE SPECIFICATIONS.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC, (BCI) INDICATING THAT A LEAK (MIXTURE OF BLOOD AND DILUENT) WAS OBSERVED FROM THE TUBING GOING TO THE SLIDE MAKER IN THE COULTER LH 750 ANALYZER. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) AT THE TIME OF THE EVENT. THERE WAS NO REPORT OF DEATH OR INJURY AND NO ONE REQUIRED MEDICAL ATTENTION. NO EXPOSURE TO OPEN WOUNDS OR MUCOUS MEMBRANES HAS BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER® LH 750 HEMATOLOGY ANALYZER GKZ BECKMAN COULTER, INC. LH 750 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1