BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 750 HEMATOLOGY ANALYXZER

    MDR report key: 3253198 · Received July 29, 2013

    Report

    Report Number
    1061932-2013-01591
    Event Type
    Malfunction
    Date Received
    July 29, 2013
    Date of Event
    July 10, 2013
    Report Date
    July 10, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K011342
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER (BEC) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE. THE FSE INSPECTED THE INSTRUMENT AND FOUND THAT THE GREEN STRIPE TUBING CONNECTED TO THE BOTTOM OF THE SHEATH FLOW COIL HAD COME OFF OF THE COIL. THE FSE REPLACED THAT SECTION OF THE GREEN STRIPE TUBING WITH A NEW PIECE THAT FIXED THE LEAK. FAILURE MODE WAS ATTRIBUTED TO A DILUENT TUBING THAT HAD POPPED OFF BEHIND THE LEFT REAR PANEL OF THE UNIT. HOWEVER, THE INSTRUMENT GENERATED BACKWASH TANK NOT FULL ERROR ALERTING THE OPERATOR TO AN INSTRUMENT PROBLEM. BECKMAN INTERNAL IDENTIFIER NUMBER FOR THIS REPORT IS (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BECKMAN COULTER (BEC) A LIQUID LEAK UNDERNEATH THE BLOOD SAMPLING VALVE (BSV) OF THE COULTER LH 750 HEMATOLOGY ANALYZER DURING A STARTUP. THE VOLUME OF THE LEAK WAS 20-30 ML WAS NOT CONTAINED WITHIN THE ANALYZER. THE INSTRUMENT GENERATED BACKWASH TANK NOT FULL ERROR. 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 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
    354194 COULTER® LH 750 HEMATOLOGY ANALYXZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER LH 750 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1