BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 780 HEMATOLOGY ANALYZER

    MDR report key: 3903529 · Received June 30, 2014

    Report

    Report Number
    1061932-2014-01415
    Event Type
    Malfunction
    Date Received
    June 30, 2014
    Date of Event
    June 1, 2014
    Report Date
    June 1, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K061616
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER (BEC) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE INSTRUMENT. THE FSE CONFIRMED THE LEAK AND ASPIRATION ERROR MESSAGES; THE ISSUES WERE RESOLVED BY REFITTING THE NEEDLE VENT TUBING AND REPLACING THE TUBING BETWEEN THE FIRST BLOOD DETECTOR AND NEEDLE ASSEMBLY. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A LEAK AND ASPIRATION ERROR MESSAGES FROM A COULTER LH 780 HEMATOLOGY ANALYZER. THE LEAK WAS NOT CONTAINED TO THE INSTRUMENT. THE OPERATOR WAS WEARING GLOVES AND A LAB COAT WHEN THE LEAK WAS FOUND. THERE WERE NO REPORTS OF DIRECT CONTACT WITH THE LEAK OR OF INJURY AS A RESULT OF THE LEAK. THE CUSTOMER REPLACED THE NEEDLE ASSEMBLY AND TUBING, BUT THE LEAK WAS NOT RESOLVED. THERE WERE NO ERRONEOUS RESULTS GENERATED IN CONNECTION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379165 COULTER LH 780 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1