BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 750 HEMATOLOGY ANALYZER

    MDR report key: 3002996 · Received March 13, 2013

    Report

    Report Number
    1061932-2013-00399
    Event Type
    Malfunction
    Date Received
    March 13, 2013
    Date of Event
    February 13, 2013
    Report Date
    February 13, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K061574
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPLACED THE TUBING THAT WAS LEAKING FLUID AROUND THE DIFFERENTIAL MIXING CHAMBER AT VL46, WHICH FIXED THE LEAK. THE UNIT IS OPERATIONAL. SERVICE WAS NOT DISPATCHED AS THE CUSTOMER CORRECTED THE ISSUE. 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 (BEC) REPORTING THAT THERE WAS A LEAK AROUND THE DIFFERENTIAL MIXING CHAMBER AT VL46 OF THE COULTER LH 750 HEMATOLOGY ANALYZER. THE VL46 CONTROLS THE RINSING OF THE LOWER CHAMBER OF THE FLOW CELL WHICH IS USED FOR BOTH DIFFERENTIAL AND RETICS PROCESSES. THE VOLUME OF FLUID WAS 7-8 MLS OF CLEAR FLUID ON THE COUNTER TOP. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF A LABORATORY COAT, GLOVES, AND EYE GLASSES DURING THIS EVENT. THERE WAS NO CONTACT TO OPEN OR BROKEN SKIN OR MUCOUS MEMBRANES. NO ONE SOUGHT MEDICAL ATTENTION. THERE WAS NO DEATH, INJURY OR AFFECT TO PATIENT TREATMENT. NO ERRONEOUS RESULTS WERE GENERATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105689 COULTER® LH 750 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER LH 750 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1