BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 780 HEMATOLOGY ANALYZER

    MDR report key: 3241617 · Received July 22, 2013

    Report

    Report Number
    1061932-2013-01488
    Event Type
    Malfunction
    Date Received
    July 22, 2013
    Date of Event
    July 2, 2013
    Report Date
    July 2, 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
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE. THE FSE CHECKED THE BLOOD SAMPLING VALVE (BSV) FOR LOOSE TUBING AND A LEAK. PER THE FSE, THERE WAS NO LEAK AT TUBING 208 OF THE BSV AND THE TUBING WAS SECURE. AS A PREVENTATIVE MEASURE THE FSE CLEANED THE BSV, PERFORMED BACKGROUND CHECK THAT PASSED AND RAN SEVERAL SAMPLES WITHOUT A LEAK. FAILURE MODE: TUBING 208 POPPED OFF THE BSV. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BECKMAN COULTER (BEC) THAT TUBING 208 POPPED OFF THE BLOOD SAMPLING VALVE (BSV) OF THE COULTER LH 780 HEMATOLOGY ANALYZER. THE OPERATOR PUT IT BACK ON, BUT THE BACK GROUND DID NOT PASS AND THE UNIT WAS STILL LEAKING. THE VOLUME OF THE LEAK WAS LESS THAN 30 ML AND WAS NOT CONTAINED WITHIN THE INSTRUMENT. THE MATERIAL SAFETY DATA SHEET (MSDS) WAS NOT 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, GOGGLES 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 EFFECT TO PATIENT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341875 COULTER® LH 780 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER LH780 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1