BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 780 HEMATOLOGY ANALYZER

    MDR report key: 3900941 · Received June 27, 2014

    Report

    Report Number
    1061932-2014-01413
    Event Type
    Malfunction
    Date Received
    June 27, 2014
    Date of Event
    May 31, 2014
    Report Date
    May 31, 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 FOUND A PLUGGED PORT IN THE DIFFERENTIAL WASTE CHAMBER; THE PORT SUPPLIES PRESSURE TO THE DIFFERENTIAL WASTE CHAMBER; AS A RESULT OF THE PLUG, THE CHAMBER WAS NOT DRAINING PROPERLY. THE FSE REMOVED THE PLUG FROM THE PORT TO RESOLVE THE LEAK. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A LEAK FROM A COULTER LH 780 HEMATOLOGY ANALYZER THAT OCCURRED DURING INSTRUMENT STARTUP. THE LEAK WAS NOT CONTAINED TO THE INSTRUMENT. THE OPERATOR WAS WEARING GLOVES, LAB COAT, AND EYEGLASSES WHEN THE LEAK WAS FOUND. THERE WERE NO REPORTS OF BIOHAZARD EXPOSURE TO MUCOUS MEMBRANES OR OPEN WOUNDS. THERE WERE NO ERRONEOUS RESULTS GENERATED AND THERE WAS NO DEATH, INJURY, OR CHANGE TO PATIENT TREATMENT ATTRIBUTED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    376567 COULTER LH 780 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1