BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 600 SYNCHRON SYSTEM

    MDR report key: 3870889 · Received June 12, 2014

    Report

    Report Number
    2050012-2014-00302
    Event Type
    Malfunction
    Date Received
    June 12, 2014
    Date of Event
    May 23, 2014
    Report Date
    May 23, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: COLLAR WASH.

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) CONFIRMED FLUID LEAKED FROM THE REAGENT PROBE B COLLAR WASH WHILE IN STANDBY. THE FSE REPLACED THE 2-WAY VALVE AND RESOLVED THE FLUID LEAK ISSUE. SERVICE ACTIVITY PERFORMED WAS VERIFIED PER SPECIFICATIONS. THE INSTRUMENT CONFORMED TO THE MANUFACTURER'S PUBLISHED PERFORMANCE SPECIFICATIONS AND WAS RETURNED TO NORMAL OPERATION. THE 2-WAY VALVE WAS RETURNED AND TESTED BY BECKMAN COULTER CUSTOMER PRODUCT LINE SUPPORT (CPLS) LABORATORY. A VISUAL EXAMINATION REVEALED NO DEFECTS. BECKMAN COULTER PERFORMED THREE PERFORMANCE VERIFICATION TESTS (PVTS): REAGENT PROBES, NORMAL TEST, AND ON-LINE DILUTION WITH ACCEPTABLE RESULTS; NO FLUID LEAK WAS OBSERVED. BECKMAN COULTER PERFORMED 20 REAGENT DELIVERY SUBSYSTEM PRIMES TO VERIFY SYSTEM OPERATION. IN SUMMARY, BECKMAN COULTER WAS UNABLE TO CONFIRM A DEFINITIVE MALFUNCTION. IN CONCLUSION, HARDWARE IS THE LIKELY CAUSE OF THE EVENT AS SYSTEM REPAIR AND ALIGNMENTS RESOLVED THE REPORTED ISSUE. HOWEVER, A SPECIFIC HARDWARE COMPONENT WAS NOT IDENTIFIED AS THE SINGULAR CAUSE OF THE EVENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED BETWEEN 15 TO 20 MILLILITERS OF DEIONIZED (DI) WATER FILLED THE CARTRIDGE CHEMISTRY (CC) REAGENT DRIP TRAY DURING SYSTEM STARTUP INVOLVING THE UNICEL DXC 600 SYNCHRON SYSTEM. THE CUSTOMER ALSO NOTED FLUID WAS IN THE CC REAGENT COMPARTMENT. THE FLUID WAS CONTAINED WITHIN THE INSTRUMENT. THE CUSTOMER USED PAPER TOWELS TO CLEAN UP THE FLUID. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF GLOVES AND A LABORATORY COAT AND DID HAVE DIRECT CONTACT WITH THE FLUID. THE CUSTOMER WASHED THE HANDS WITH WATER SEVERAL TIMES AND DID NOT SEEK MEDICAL ATTENTION. THERE WAS NO OPERATOR INJURY OR ADVERSE EFFECT ASSOCIATED WITH THIS EVENT. THE CUSTOMER WAS NOT AWARE OF ANY ERRONEOUS PATIENT RESULTS AT THE TIME OF THE FLUID LEAK. THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THIS EVENT. THE CUSTOMER INDICATED THE FACILITY HAS A 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
    347011 UNICEL DXC 600 SYNCHRON SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1