BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXH 800 COULTER® CELLULAR ANALYSIS SYSTEM

    MDR report key: 2924174 · Received January 22, 2013

    Report

    Report Number
    1061932-2013-00080
    Event Type
    Malfunction
    Date Received
    January 22, 2013
    Date of Event
    December 27, 2012
    Report Date
    December 27, 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
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BEC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE. THE FSE FOUND EVIDENCE OF A LEAK WHEN OBSERVED DRIED DEPOSITS OF REAGENT FROM VACUUM CHAMBER 222 (VC222) ON THE CHAMBER AND ON THE VALVE 222 (VL222) WHICH IS ASSOCIATED WITH THE VC222. THE FSE REPLACED THE VACUUM CHAMBER 222 AND VALVE 222 TO RESOLVE THE LEAK. PER THE FSE, THE CHAMBER DID NOT APPEAR TO BE CRACKED OR DAMAGED. 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. THE CAUSE OF THE LEAK WAS VACUUM CHAMBER 222 LEAKING ON TO VALVE 222. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC., (BEC), TO REPORT THAT THE UNICEL DXH 800 COULTER INSTRUMENT WAS LEAKING A SLIGHTLY GREEN TINGED FLUID WITH A VOLUME OF LESS THAN 5ML. THE LEAK WAS CONTAINED WITHIN THE INSTRUMENT. THE MATERIAL SAFETY DATA SHEET (MSDS) WAS NOT REVIEWED. THERE IS AN EXPOSURE CONTROL PLAN AT THE FACILITY. THE OPERATOR WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) INCLUDING A LAB COAT, EYEWEAR AND GLOVES. THERE WAS NO EXPOSURE TO MUCOUS MEMBRANES OR OPEN WOUNDS. NO ONE WAS SPLASHED, SPRAYED OR INJURED. NO ONE SOUGHT MEDICAL ATTENTION. NO PATIENT RESULTS WERE AFFECTED. THERE WAS NO DEATH, INJURY OR EFFECT TO PATIENT TREATMENT ATTRIBUTED OR ASSOCIATED TO THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30544 UNICEL® DXH 800 COULTER® CELLULAR ANALYSIS SYSTEM COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER, INC. N/A

    Patients

    Seq Age Sex Outcome Treatment
    1