BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXH 800 COULTER® CELLULAR ANALYSIS SYSTEM

    MDR report key: 2466415 · Received February 23, 2012

    Report

    Report Number
    1061932-2012-00616
    Event Type
    Malfunction
    Date Received
    February 23, 2012
    Date of Event
    January 30, 2012
    Report Date
    January 30, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K081930
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PROBE WIPE ASSEMBLY AND ASSOCIATED TUBING COULD CONTAIN BLOOD, CONTROLS, OR DXH DILUENT DURING NORMAL OPERATION OR DXH CLEANER DURING SHUTDOWN. PER LABELING, BECKMAN COULTER, INC. URGES ITS CUSTOMERS TO COMPLY WITH ALL NATIONAL HEALTH AND SAFETY STANDARDS 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. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON (B)(4) 2012 FOR THIS EVENT. THE FSE FOUND THAT WASTE VACUUM TUBING CAME LOOSE FROM QD421. THE LEAK WAS CONTAINED TO THE CASSETTE MIXING AREA. THE TUBING HAD BEEN REPLACED THE PREVIOUS DAY AS PART OF MODIFICATION FOR THE DXH 800 PROBE WASH TUBING ROUTING IMPROVEMENT. THE TUBING WAS RECONNECTED AND VERIFIED THAT IT WAS INSTALLED OVER THE BARB. STARTUP AND QC WAS PERFORMED WITH GOOD RESULTS AND THE INSTRUMENT WAS OPERATIONAL. THE CAUSE FOR THE LEAK IS THE PROBE WIPE ASSEMBLY WASTE VACUUM TUBING CAME LOOSE FROM QD421. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC., (BEC) AND REPORTED THAT THEY OBSERVED BLOOD ALL OVER RACKS (CASSETTES) FROM A LEAK ON THE UNICEL DXH 800 COULTER INSTRUMENT. THE OPERATOR WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF A LAB COAT AND GLOVES, WITH NO FACE PROTECTION. THERE WAS NO EXPOSURE TO MUCOUS MEMBRANE OR OPEN WOUNDS AND THE OPERATOR DID NOT SEEK MEDICAL ATTENTION. THE LABORATORY HAS AN EXPOSURE CONTROL/RISK MANAGEMENT PLAN IN PLACE. MATERIAL SAFETY DATA SHEET (MSDS) WAS NOT REVIEWED; HOWEVER, IT IS READILY AVAILABLE ON THE BEC WEBSITE. THERE WAS NO IMPACT TO PATIENT RESULTS ATTRIBUTED TO THIS EVENT. THERE WAS NO DEATH, INJURY, OR AN EFFECT TO PATIENT TREATMENT ATTRIBUTED OR ASSOCIATED TO THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXH 800 COULTER® CELLULAR ANALYSIS SYSTEM COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER, INC. DXH 800 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1