BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 750 HEMATOLOGY ANALYZER

    MDR report key: 3962215 · Received July 28, 2014

    Report

    Report Number
    1061932-2014-01790
    Event Type
    Malfunction
    Date Received
    July 28, 2014
    Date of Event
    July 3, 2014
    Report Date
    July 3, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K011342
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2014, A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) EVALUATED THE ANALYZER AND FOUND DAMAGED TUBING. THE TUBING WAS A PORTION OF THE OUTPUT LINE FROM THE LYSE 3-DIFF PUMP (PM7) LEADING TO THE WBC (WHITE BLOOD CELL) BATH. THE TUBING WAS REPLACED, CORRECTING THE LEAK. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE HEMOGLOBIN READINGS FOR BLANK AND READ WERE AT 0.0 AND THE INSTRUMENT WAS NOT RECOVERING HEMOGLOBIN VALUES WHEN USING THE COULTER LH 750 HEMATOLOGY ANALYZER. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE CUSTOMER'S FACILITY TO EVALUATE THE ANALYZER. THE FSE IDENTIFIED A CONTAINED 10 ML LEAK CAUSED BY TORN TUBING. THE OPERATOR WAS WEARING GLOVES, PROTECTIVE EYEWEAR, AND A LAB COAT AT THE TIME OF THE INCIDENT. THERE WAS NO BIOHAZARD EXPOSURE TO OPEN WOUNDS OR MUCOUS MEMBRANES. THERE WAS NO REPORT OF ERRONEOUS TEST RESULTS ASSOCIATED WITH THIS EVENT. THERE WAS NO DEATH, INJURY OR AFFECT TO USER OR PATIENT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439750 COULTER LH 750 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1