BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LH 500 HEMATOLOGY SYSTEM

    MDR report key: 2355207 · Received December 1, 2011

    Report

    Report Number
    1061932-2011-02455
    Event Type
    Malfunction
    Date Received
    December 1, 2011
    Date of Event
    November 8, 2011
    Report Date
    November 8, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K032000
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    BECKMAN COULTER UNIQUE IDENTIFIER IS (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THERE WAS A BLUE LIQUID LEAK AROUND PV 66 ON THE LH500 INSTRUMENT BUT COULD NOT PINPOINT THE SOURCE. THE CUSTOMER WAS RUNNING A STARTUP WHEN THE LEAK WAS DISCOVERED. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF A LAB COAT AND GLOVES. THE CUSTOMER DID NOT COME IN CONTACT WITH THE FLUID. MEDICAL ATTENTION WAS NOT SOUGHT. THERE WAS NO REPORT OF EXPOSURE TO MUCOUS MEMBRANES OR OPEN WOUNDS. NO ONE WAS SPLASHED OR SPRAYED. THE MATERIAL SAFETY DATA SHEET (MSDS) WAS NOT REVIEWED. THERE WAS NO DEATH, INJURY OR CHANGE TO PATIENT TREATMENT ATTRIBUTED OR ASSOCIATED TO THIS COMPLAINT, NOR WAS THERE IMPACT TO PATIENT RESULTS AS A RESULT OF THIS EVENT. THE FIELD SERVICE ENGINEER (FSE) OBSERVED THE SOURCE OF THE LEAK WAS THE TUBING GOING THROUGH PINCH VALVE (PV) 66. PV66 (SWEEP FLOW VENT) IS DRIVEN BY SOLENOID 2 AND IS RESPONSIBLE FOR THE RBC PROCESS. THE FSE REPLACED THE TUBING. THERE WAS NO FURTHER EVIDENCE OF LEAKING. ROOT CAUSE FOR THE LEAK WAS A CUT TUBING GOING THROUGH PV66. PER LABELING, BECKMAN COULTER, INC. URGES ITS CUSTOMERS TO COMPLY WITH ALL (B)(4) SUCH AS THE USE OF BARRIER PROTECTION. THIS MAY INCLUDE, BUT IT IS NOT LIMITED TO, PROTECTIVE EYEWEAR, GLOVES, AND SUITABLE LABORATORY ATTIRE WHEN OPERATING OR MAINTAINING THIS OR ANY OTHER AUTOMATED LABORATORY ANALYZER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LH 500 HEMATOLOGY SYSTEM COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER, INC. LH 500

    Patients

    Seq Age Sex Outcome Treatment
    1