BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 780 HEMATOLOGY ANALYZER

    MDR report key: 3212191 · Received July 9, 2013

    Report

    Report Number
    1061932-2013-01322
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Date of Event
    June 13, 2013
    Report Date
    June 13, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K061616
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) SPOKE TO THE CUSTOMER ON THE PHONE AND HAD THE CUSTOMER TO CHANGE A DEFECTIVE CHECK VALVE ON THE WASTE DRAIN LINE WHICH DRAINS THE DIFFERENTIAL WASTE CHAMBER THAT FIXED THE LEAK. WHEN THE FSE ARRIVED AT THE FACILITY THE WASTE CHAMBER ON THE UNIT WAS EMPTY. THE FSE STARTED THE ANALYZER AND THE INSTRUMENT PERFORMED AS EXPECTED. NO LEAK WAS OBSERVED. FAILURE MODE WAS ATTRIBUTED TO A DEFECTIVE CHECK VALVE ON THE WASTE DRAIN LINE. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BECKMAN COULTER (BEC) STATING THAT THERE WAS A LEAK BEHIND THE COULTER LH 780 HEMATOLOGY ANALYZER THROUGH VENT #156. THE VOLUME OF THE LEAK WAS 10 ML AND WAS NOT CONTAINED WITHIN THE INSTRUMENT. THE MATERIAL SAFETY DATA SHEET (MSDS) WAS REVIEWED BY THE CUSTOMER. THERE IS AN EXPOSURE CONTROL PLAN AT THE FACILITY. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE), INCLUDING A LABORATORY COAT, EYEGLASSES AND GLOVES. NO ONE WAS SPLASHED, SPRAYED OR INJURED. THERE WAS NO CONTACT OR BIOHAZARD EXPOSURE TO OPEN OR BROKEN SKIN OR MUCOUS MEMBRANES. NO ONE SOUGHT MEDICAL ATTENTION. NO ERRONEOUS RESULTS WERE GENERATED IN CONNECTION WITH THIS EVENT. THERE WAS NO DEATH, INJURY OR AFFECT TO PATIENT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313807 COULTER® LH 780 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER LH780 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1