BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER HMX HEMATOLOGY ANALYZER WITH AUTOLOADER

    MDR report key: 2180974 · Received July 1, 2011

    Report

    Report Number
    1061932-2011-00651
    Event Type
    Malfunction
    Date Received
    July 1, 2011
    Date of Event
    March 9, 2010
    Report Date
    March 9, 2010
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K010765
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BECKMAN COULTER INC. URGES CUSTOMERS TO COMPLY WITH ALL NATIONAL HEALTH AND SAFETY STANDARDS SUCH AS THE USE OF BARRIER PROTECTION. THIS MAY INCLUDE, BUT IS NOT LIMITED TO, PROTECTIVE EYEWEAR, GLOVES, AND SUITABLE LABORATORY ATTIRE WHEN OPERATING OR MAINTAINING THIS OR ANY OTHER AUTOMATED LABORATORY ANALYZER. THE FIELD SERVICE ENGINEER EVALUATED THE ANALYZER FOR THE REPORTED AMBIENT TEMPERATURE ERRORS AFTER TUBING ON PINCH VALVE 40 BECAME DISCONNECTED. FLUID WAS SPRAYED ON PELTIER AND PELTIER FAN. REPLACED DEFECTIVE PELTIER FAN. PERFORMED SYSTEM VERIFICATION AND OBTAINED LOW VACUUM ON SYSTEM TEST. EVALUATED THE LOW VACUUM ERROR. ADJUSTED AND RESEATED VACUUM TUBING. REPLACED DEFECTIVE DRYER. RESUMED WITH SYSTEM VERIFICATION. LOW VACUUM RESOLVED. PERFORMED LATRON, REPRODUCIBILITY, MODE TO MODE COMPARISON, AND QUALITY CONTROL. ANALYZER THEN MET SPECIFICATIONS. ROOT CAUSE WAS THE INITIAL DISCONNECTION OF TUBING ON PINCH VALVE 40 BY THE OPERATOR. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW CONDUCTED BETWEEN JANUARY 1, 2008 AND OCTOBER 23, 2010 OF COMPLAINTS FOR ADD'L REPORTABLE EVENTS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED A POTENTIAL BIOHAZARD EXPOSURE WHILE USING THE COULTER HMX HEMATOLOGY ANALYZER WITH AUTOLOADER. THE OPERATOR WAS EVALUATED THE ANALYZER TO DETERMINE THE CAUSE OF A FLUID LEAK WHEN HE WAS SPRAYED ON THE FACE AND IN THE EYE WITH FLUID. THE OPERATOR WAS WEARING GLOVES. THE OPERATOR WAS NOT WEARING EYE PROTECTION. THE OPERATOR WASHED HIS FACE. HE DID NOT SEEK MEDICAL ATTENTION. THE OPERATOR STATED THAT HIS WORKPLACE HAS BASELINES FOR INFECTIOUS AGENTS DRAWN ONCE A YR AS PROTOCOL. NO REPORTS OF DEATH OR SERIOUS INJURY AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER HMX HEMATOLOGY ANALYZER WITH AUTOLOADER GKZ BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK