BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 750 HEMATOLOGY ANALYZER

    MDR report key: 3831575 · Received May 25, 2014

    Report

    Report Number
    1061932-2014-01163
    Event Type
    Malfunction
    Date Received
    May 25, 2014
    Date of Event
    May 5, 2014
    Report Date
    May 5, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K011342
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED. THE FSE REPLACED VALVE CV47 WHICH IS A CHECK VALVE LOCATED IN THE DRAIN PATH OF THE NEEDLE BELLOWS. IN ADDITION, THE FSE INDICATED THAT THE 5C DIFFERENTIAL (DIFF) AND RETICULOCYTE (RETIC) CONTROLS WERE BOTH RUNNING ON THE LOW SIDE. TO RESOLVE THE CONTROL RECOVERY ISSUE, THE DIFF AND THE RETIC SHEAR VALVES (BLOOD SEGMENT VALVES) WERE REPLACED. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED LESS THAN 1 MILLILITER OF FLUID OVERFLOWING FROM THE NEEDLE BELLOWS OF THE LH750 INSTRUMENT. THE FLUID WENT ONTO THE TUBE SAMPLE CAPS AS THE TUBES WERE BEING PIERCED. THERE WAS NO BIOHAZARD EXPOSURE TO OPEN WOUNDS OR MUCOUS MEMBRANES. NO ERRONEOUS PATIENT RESULTS WERE GENERATED IN CONNECTION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309825 COULTER LH 750 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1