BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM

    MDR report key: 3895549 · Received June 25, 2014

    Report

    Report Number
    1061932-2014-01483
    Event Type
    Malfunction
    Date Received
    June 25, 2014
    Date of Event
    June 3, 2014
    Report Date
    June 3, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K081930
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) OBSERVED THE PROBE WASTE VACUUM VALVE VL343 WAS NOT ACTUATING AND REPLACED THE PINCH VALVE TO RESOLVE THE FLUID LEAK ISSUE. SERVICE ACTIVITY PERFORMED WAS VERIFIED TO MEET THE SPECIFIED REQUIREMENTS PER ESTABLISHED PROCEDURES. THE INSTRUMENT CONFORMED TO THE MANUFACTURER'S PUBLISHED PERFORMANCE SPECIFICATIONS AND WAS RETURNED TO NORMAL OPERATION. IN CONCLUSION, THE LIKELY CAUSE OF THE FLUID LEAK IS ATTRIBUTED TO THE PROBE WASTE VACUUM VALVE VL343. (B)(4).

    Description of Event or Problem · 1

    THE AFFILIATE STATED THE CUSTOMER REPORTED A SMALL AMOUNT OF DILUENT LEAKED BELOW THE PROBE INVOLVING THE UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM. THE FLUID WAS CONTAINED WITHIN THE INSTRUMENT. THE CUSTOMER HAD REPLACED THE PROBE BUT IT DID NOT RESOLVE THE ISSUE. THE OPERATOR WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF GLOVES AND A LABORATORY COAT AND DID NOT HAVE DIRECT CONTACT WITH THE FLUID. THERE WAS NO OPERATOR INJURY OR ADVERSE EFFECT ASSOCIATED WITH THIS EVENT. NO ERRONEOUS PATIENT RESULTS WERE GENERATED. THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THIS EVENT. THE FACILITY HAS AN EXPOSURE CONTROL AND RISK MANAGEMENT PLAN IN PLACE FOR BIOHAZARD MATERIAL. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ASSESS THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370893 UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1