BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 750 HEMATOLOGY ANALYZER

    MDR report key: 4243596 · Received November 11, 2014

    Report

    Report Number
    1061932-2014-02808
    Event Type
    Malfunction
    Date Received
    November 11, 2014
    Date of Event
    October 18, 2014
    Report Date
    October 18, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K011342
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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 CONFIRMED THE BLOOD SAMPLING VALVE KNOB (BSV) WAS LOOSE. THE FSE REPLACED THE BSV KNOB AND SHAFT RESOLVING THE LEAK REPORTED. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED A LEAK WHEN USING THE COULTER LH 750 HEMATOLOGY ANALYZER. THE CUSTOMER NOTED THE BLOOD SAMPLING VALVE (BSV) KNOB WAS LOOSE AND THEN IDENTIFIED A LEAK. THE LEAK WAS DESCRIBED AS A SMALL DRIP OF CLEAR LIQUID, APPROXIMATELY 2 ML, FROM THE SAMPLE PROBE ONTO THE COUNTERTOP. THE INSTRUMENT WAS NOT IN USE FOR PATIENT SAMPLES. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE CUSTOMER'S FACILITY TO EVALUATE THE ANALYZER. THE OPERATOR WAS WEARING GLOVES, EYE PROTECTION, AND LAB COAT AT THE TIME THE LEAK WAS DISCOVERED. 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
    727104 COULTER LH 750 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1