BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 750 HEMATOLOGY ANALYXZER

    MDR report key: 3171178 · Received June 14, 2013

    Report

    Report Number
    1061932-2013-01079
    Event Type
    Malfunction
    Date Received
    June 14, 2013
    Date of Event
    May 21, 2013
    Report Date
    May 21, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K011342
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BECKMAN COULTER (BEC) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE. THE FSE INSPECTED THE INSTRUMENT AND OBSERVED THAT THERE WAS A LOOSE WASTE/RINSE BLOCK ON THE PROBE WIPE MODULE OF THE INSTRUMENT. THE FSE REPAIRED THE LOOSE RINSE BLOCK AND VERIFIED THE INSTRUMENT PERFORMANCE. FAILURE MODE WAS RELATED TO A LOOSE RINSE BLOCK ON THE PROBE WIPE MODULE. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BECKMAN COULTER (BEC) THAT THERE WAS A BLUE FLUID LEAK OF APPROXIMATELY 1ML FROM THE MANUAL ASPIRATION AREA OF THE COULTER LH 750 HEMATOLOGY ANALYZER. THE LEAK WAS CONTAINED WITHIN THE INSTRUMENT. THE MATERIAL SAFETY DATA SHEET (MSDS) WAS NOT REVIEWED BY THE CUSTOMER. THERE IS AN EXPOSURE CONTROL/RISK MANAGEMENT PLAN IN PLACE AT THE FACILITY. THE OPERATOR WAS WEARING A LABORATORY COAT, PROTECTIVE EYEWEAR AND GLOVES AT THE TIME OF THE INCIDENT. THERE WAS NO BIOHAZARD EXPOSURE TO OPEN WOUNDS OR MUCOUS MEMBRANES. THE OPERATOR DID NOT SEEK MEDICAL ATTENTION. NO ERRONEOUS RESULTS WERE ASSOCIATED WITH THE REPORTED EVENT. NO DEATH OR INJURY WAS ATTRIBUTED TO THIS EVENT AND THERE WAS NO CHANGE TO PATIENT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270549 COULTER® LH 750 HEMATOLOGY ANALYXZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER LH 750 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1