BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 880I SYNCHRON ® ACCESS CLINICAL SYSTEM

    MDR report key: 3121216 · Received May 20, 2013

    Report

    Report Number
    2050012-2013-00317
    Event Type
    Malfunction
    Date Received
    May 20, 2013
    Date of Event
    April 22, 2013
    Report Date
    April 22, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K060256
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER FSE (FIELD SERVICE ENGINEER) WAS DISPATCHED AND FOUND EVIDENCE OF A CAP PIERCER LEAK AS THERE WAS WASH BUFFER INT HE DRIP TRAY BELOW THE CAP PIERCER. THE FSE ATTEMPTED TO DUPLICATE THE ISSUE BY EXERCISING THE CAP PIERCER WASTE VALVE AND RUNNING MULTIPLE TUBES THROUGH THE CAP PIERCER BUT WAS UNABLE TO DUPLICATE THE LEAK. SINCE THE PROBLEM WAS INTERMITTENT AND THE CAP PIERCER HAD BEEN PREVIOUSLY REPLACED BY ANOTHER FSE ON A PREVIOUS CALL FOR THE SAME ISSUE, THE FSE DECIDED TO REPLACE THE REMAINING TWO ITEMS THAT CONTROL THE CAP PIERCER WASH WHICH ARE THE SMART MODULE 42 AND THE SOLENOID HARNESS. FAILURE MODE IS ATTRIBUTED TO THE SMART MODULE 42 AND SOLENOID VALVE. BECKMAN COULTER INTERNAL IDENTIFIER FOR THIS REPORT IS (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A CONTAINED CAP PIERCER LEAK INVOLVING THE UNICEL DXC 880I SYNCHRON ACCESS CLINICAL SYSTEM. THE CUSTOMER STATED THAT APPROXIMATELY 5 TO 10 ML OF FLUID LEAKED AND FLUID WAS OBSERVED ON THE SAMPLE TUBE CAPS AND RACKS. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT CONSISTING OF GLOVES, GOGGLES, AND A LABORATORY COAT AT THE TIME OF THE EVENT AND NO INJURY OR EXPOSURE WAS REPORTED. NO ERRONEOUS RESULTS WERE GENERATED AND THERE WAS NO CHANGE OR AFFECT TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222126 UNICEL® DXC 880I SYNCHRON ® ACCESS CLINICAL SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1