BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 780 HEMATOLOGY ANALYZER

    MDR report key: 4092487 · Received September 16, 2014

    Report

    Report Number
    1061932-2014-02324
    Event Type
    Malfunction
    Date Received
    September 16, 2014
    Date of Event
    August 24, 2014
    Report Date
    August 24, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K061616
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    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 FOUND LOOSE SAMPLE LINE TUBING AT THE BLOOD SAMPLING VALVE, WHICH CAUSED THE LEAK DURING THE BACKWASH CYCLE. THE TUBING WAS REPLACED TO RESOLVE THE LEAK. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED FINDING FLUID FROM AN UNKNOWN SOURCE INSIDE A COULTER LH 780 HEMATOLOGY ANALYZER. THE LEAK WAS CONTAINED WITHIN THE INSTRUMENT. THE INSTRUMENT OPERATOR WAS WEARING PROPER PERSONAL PROTECTIVE EQUIPMENT AT THE TIME OF THE LEAK; THE EXACT DETAILS OF PERSONAL PROTECTIVE EQUIPMENT ARE NOT KNOWN. THERE WERE NO REPORTS OF BIOHAZARD EXPOSURE TO THE LEAK. THERE WERE NO ERRONEOUS RESULTS GENERATED IN CONNECTION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    572955 COULTER LH 780 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1