BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 750 HEMATOLOGY ANALYZER

    MDR report key: 3840024 · Received May 30, 2014

    Report

    Report Number
    1061932-2014-01130
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Date of Event
    April 30, 2014
    Report Date
    April 30, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K011342
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER (BEC) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ASSESS THE INSTRUMENT. THE FSE DID NOT CONFIRM A LEAK FROM THE SHEAR VALVES BUT THE FSE FOUND THE FRONT BLOOD DETECTOR TUBING TO THE BLOOD SAMPLING VALVE (BSV) DISCONNECTED AT THE BLOOD DETECTOR. THE FSE REPLACED THE TUBING AND THE PATHWAY WAS BACK FLUSH TO RESOLVE THE PARTIAL ASPIRATION ERRORS REPORTED. THE FSE ALSO NOTICED THAT THE BSV WAS NOT SEALING PROPERLY AND THE BSV WAS REPLACED. THE INSTRUMENT WAS RETURNED TO NORMAL OPERATION. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED GETTING PARTIAL ASPIRATIONS (P) ERRORS AND A CONTAINED LEAK FROM THE SHEAR VALVES OF THE COULTER LH 750 HEMATOLOGY ANALYZER. THE VOLUME OF THE LEAK WAS 1 ML OF CLEAR FLUID. A BECKMAN COULTER (BEC) CUSTOMER TECHNICAL SPECIALIST (CTS) INDICATED THAT THE CUSTOMER HAD FOUND AND ADDRESSED THE LEAK BY REATTACHING THE TUBING TO THE DIFF SHEAR VALVES, AND THAT THE INSTRUMENT WAS GIVING PARTIAL ASPIRATION ERRORS. THE LEAK WAS CONTAINED WITHIN THE INSTRUMENT. THERE WAS NO REPORTED EXPOSURE TO MUCOUS MEMBRANES OR OPEN WOUNDS. THE CUSTOMER WAS WEARING GLOVES AND LAB COAT. NO ERRONEOUS RESULTS WERE GENERATED IN CONNECTION WITH THE REPORTED EVENT. THERE WAS NO DEATH, INJURY, OR AFFECT TO USER OR TO PATIENT TREATMENT ATTRIBUTED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319579 COULTER LH 750 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1