BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 750 HEMATOLOGY ANALYZER

    MDR report key: 2260796 · Received September 22, 2011

    Report

    Report Number
    1061932-2011-01524
    Event Type
    Malfunction
    Date Received
    September 22, 2011
    Date of Event
    August 24, 2011
    Report Date
    August 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
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED FOR THE EVENT. THE FSE DETERMINED THAT A BLOOD CLOT IN THE PROBE WASH BLOCK OR ITS ASSOCIATED DRAIN PATHWAY CAUSED THE BACKUP OF FLUID. THE PROBE WASH BLOCK AND ALL ASSOCIATED DRAIN PATHWAYS WERE CLEANED OF ALL DEBRIS. THE REPAIRS WERE VERIFIED PER ESTABLISHED PROCEDURES. PER LABELING, BECKMAN COULTER, INC. URGES ITS CUSTOMERS TO COMPLY WITH ALL NATIONAL HEALTH AND SAFETY STANDARDS SUCH AS THE USE OF BARRIER PROTECTION. THIS MAY INCLUDE, BUT IT IS NO LIMITED TO, PROTECTIVE EYEWEAR, GLOVES, AND SUITABLE LABORATORY ATTIRE WHEN OPERATING OR MAINTAINING THIS OR ANY OTHER AUTOMATED LABORATORY ANALYZER. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT THE RINSE CUP OF THE COULTER LH 750 HEMATOLOGY ANALYZER WAS NOT DRAINING PROPERLY AND BLOOD MIXED WITH DILUENT FROM THE CUP SPILLED ONTO THE INSTRUMENT. THE USER WAS WEARING PROPER PROTECTIVE EQUIPMENT CONSISTING OF A LAB COAT, GLOVES, AND EYE PROTECTION AT THE TIME OF THE INCIDENT. THE CUSTOMER DID NOT COME IN CONTACT WITH THE FLUID AND MEDICAL ATTENTION WAS NOT SOUGHT. THERE WAS NO REPORT OF EXPOSURE TO MUCOUS MEMBRANES OR OPEN WOUNDS. NO ONE WAS SPLASHED OR SPRAYED. THERE WAS NO DEATH, INJURY OR CHANGE TO PATIENT TREATMENT AS A RESULT OF THIS INCIDENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1