BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 780 HEMATOLOGY ANALYZER

    MDR report key: 2902501 · Received January 8, 2013

    Report

    Report Number
    1061932-2013-00020
    Event Type
    Malfunction
    Date Received
    January 8, 2013
    Date of Event
    December 11, 2012
    Report Date
    December 11, 2012
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    GKZ
    PMA / PMN Number
    K061574
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BEC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON (B)(4) 2012 AND OBSERVED MULTIPLE LEAKS AROUND TRIPLE TRANSDUCER MODULE (TTM). THE LEAK WAS COMING FROM THE BLACK STRIPE TUBING GOING THROUGH THE VL50, FROM THE FLOW CELL PORT 5 AND THE SAMPLE LINE AT BOTTOM OF FLOW CELL. THE FSE REPLACED THE MULTIPLE TUBING AROUND TTM. THE FLOW CELL WAS CLEANED AND THE TTM WAS OPTIMIZED. THE FSE ALSO VERIFIED INSTRUMENT AS PER PROCEDURE, ISSUE WAS RESOLVED. FAILURE MODE IS ASSOCIATED WITH THE BLACK STRIPE TUBING GOING THROUGH VL50, FLOW CELL PORT 5, AND SAMPLE LINE AT BOTTOM OF FLOW CELL. 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 NOT 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 CONTACTED BECKMAN COULTER INC. (BEC) REPORTING THAT THE CUSTOMER NOTICED AN EXTERNAL LEAK (VOLUME UNKNOWN) AT THE CENTER OF THE COULTER LH 780 HEMATOLOGY ANALYZER AND ONTO THE COUNTERTOP WHICH APPEARED TO BE DILUENT. THE OPERATOR WAS WEARING GLOVES AND LAB COAT DURING THIS EVENT. THERE WAS NO BIOHAZARD EXPOSURE TO OPEN WOUNDS OR MUCOUS MEMBRANES. NO ONE SOUGHT MEDICAL ATTENTION. NO ERRONEOUS RESULTS WERE GENERATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9995 COULTER® LH 780 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER INC. LH 780 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1