BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 750 HEMATOLOGY ANALYXZER

    MDR report key: 3230410 · Received July 16, 2013

    Report

    Report Number
    1061932-2013-01474
    Event Type
    Malfunction
    Date Received
    July 16, 2013
    Date of Event
    June 27, 2013
    Report Date
    June 27, 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
    CT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER (BEC) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE ON (B)(4) 2013. THE FSE INSPECTED THE INSTRUMENT AND FOUND CUT BLACK-STRIPE TUBING THROUGH VALVE VL46B. THE FSE REPLACED THE TUBING AND CLEANED UP DILUENT. ONLY DILUENT GOES THROUGH THIS TUBING, THERE WAS NO BLOOD SPILLED DUE TO THE CUT TUBING. THE INSTRUMENT WAS VERIFIED WITH A STARTUP, LATRON, CONTROLS, AND REPRODUCIBILITY. FAILURE MODE WAS ATTRIBUTED TO CUT BLACK-STRIPE TUBING THROUGH VALVE VL46B. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BECKMAN COULTER (BEC) THAT THERE WAS A LEAK OF CLEAR FLUID (50 ML) FROM THE COULTER LH 750 HEMATOLOGY ANALYZER ON THE COUNTER AND FLOOR. THE MATERIAL SAFETY DATA SHEET (MSDS) WAS NOT REVIEWED BY THE CUSTOMER. THERE IS AN EXPOSURE CONTROL PLAN AT THE FACILITY. THE CUSTOMER WAS WEARING A LABORATORY COAT, GLOVES AND GOGGLES AT THE TIME OF THE EVENT. THERE WAS NO BIOHAZARD EXPOSURE TO OPEN WOUNDS OR MUCOUS MEMBRANES. NO ONE SOUGHT MEDICAL ATTENTION. NO PATIENT SAMPLES WERE AFFECTED. NO ERRONEOUS RESULTS WERE GENERATED IN CONNECTION WITH THIS EVENT. THERE WAS NO DEATH, INJURY, OR EFFECT TO PATIENT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    327965 COULTER® LH 750 HEMATOLOGY ANALYXZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER LH 750 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1