BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 500 HEMATOLOGY ANALYZER

    MDR report key: 3222786 · Received July 12, 2013

    Report

    Report Number
    1061932-2013-01458
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Date of Event
    June 18, 2013
    Report Date
    June 18, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K032000
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE ON (B)(4) 2013. THE FSE INSPECTED THE INSTRUMENT AND DISCOVERED THAT THE TUBING THROUGH PINCH VALVE (PV27) HAD BECOME DISCONNECTED FROM THE T FITTING GOING TO THE DIFFERENTIAL LYSE PUMP. THE PV27 CONTROLS THE ERYTHROLYSE II REAGENT PATH TO REAGENT PUMPS (PM6 AND PM7). THE FSE REPLACED THE TUBING AND THE INSTRUMENT RAN WITHOUT ANY LEAKS AND PASSED THE STARTUP. THE FSE VERIFIED THE REPAIRS PER ESTABLISHED PROCEDURES. THE CAUSE OF THE LEAK WAS THE TUBING THROUGH PINCH VALVE PV27 HAD BECOME DISCONNECTED FROM THE T FITTING GOING TO THE DIFFERENTIAL LYSE PUMP. HOWEVER, THE INSTRUMENT OPERATED AS INTENDED BY GENERATING FAILING STARTUP, ALERTING THE OPERATOR TO AN INSTRUMENT PROBLEM. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BECKMAN COULTER (BEC) A LEAK INSIDE THE COULTER LH 500 HEMATOLOGY ANALYZER. THE CUSTOMER INDICATED THAT THE STARTUP WAS FAILING WHEN THE LEAK WAS NOTICED. THE VOLUME OF THE LEAK WAS ABOUT 10 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/RISK MANAGEMENT PLAN IN PLACE AT THE FACILITY. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE), CONSISTING OF GLOVES, FACE PROTECTION AND A LABORATORY COAT AT THE TIME OF THE OCCURRENCE. NO ONE CAME IN CONTACT WITH THE FLUID. THERE WAS NO BIOHAZARD EXPOSURE TO OPEN WOUNDS OR MUCOUS MEMBRANES. MEDICAL ATTENTION WAS NOT SOUGHT. NO ERRONEOUS RESULTS WERE GENERATED FOR THIS EVENT. THERE WAS NO DEATH, INJURY OR CHANGE TO PATIENT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322129 COULTER® LH 500 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER LH 500 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1