BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 780 HEMATOLOGY ANALYZER

    MDR report key: 2929090 · Received January 24, 2013

    Report

    Report Number
    1061932-2013-00053
    Event Type
    Malfunction
    Date Received
    January 24, 2013
    Date of Event
    January 2, 2013
    Report Date
    January 2, 2013
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K061616
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A BEC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER'S SITE. THE FSE FOUND A LEAK AT VALVE (VL3A) THAT CONTROLS THE FLOW TO THE COMPLETE BLOOD COUNT (CBC) LYSE PUMP. THE FSE RESET THE INSTRUMENT AND REBUILD THE MIXING RESERVOIR TUBING THAT FIXED THE LEAK. THE FSE RECALIBRATED AND VERIFIED ALL FLUID DETECTORS THAT WERE ASSOCIATED WITH THE LEAK. CAUSE OF THIS EVENT; LEAK AT THE VL3A. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC., (BEC) AND REPORTED THAT THE FD2 AND FD7 (FLUID DETECTORS) ON THE COULTER LH 780 HEMATOLOGY INSTRUMENT WERE LEAKING FLUID FROM VALVE (VL3B). THE VOLUME OF THE LEAKED FLUID WAS <5CC'S AND WAS CONTAINED WITHIN THE INSTRUMENT. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE), INCLUDING A LAB COAT AND GLOVES. NO ONE WAS SPLASHED, SPRAYED OR INJURED. THERE WAS NO CONTACT TO OPEN OR BROKEN SKIN OR MUCOUS MEMBRANES. NO ONE SOUGHT MEDICAL ATTENTION. THE MATERIAL SAFETY DATA SHEET (MSDS) WAS REVIEWED. THERE IS AN EXPOSURE CONTROL PLAN AT THE FACILITY. THERE WAS NO DEATH, INJURY OR AFFECT TO PATIENT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    34211 COULTER® LH 780 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER, INC. LH780 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1