BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEM

    MDR report key: 2955762 · Received February 11, 2013

    Report

    Report Number
    2050012-2013-00086
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Date of Event
    January 17, 2013
    Report Date
    January 17, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE. THE FSE FOUND DEBRIS INSIDE THE EIC VALVE WHICH WAS REMOVED AND THE EIC WORKED PROPERLY. THE FSE VERIFIED THE SYSTEM PERFORMANCE. BASED ON QA CONTACT WITH THE FSE ON (B)(4) 2013 VIA PHONE, THE FSE INDICATED THAT THE DEBRIS REMOVED FROM THE EIC WERE LITTLE PIECES OF RUBBER. RUBBER DEBRIS INSIDE THE ECI CAUSED THIS EVENT. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER (BEC) AND REPORTED THAT DURING REPLACEMENT OF THE CARBON DIOXIDE (CO2) ACID REAGENT THEY NOTICED THAT THE EIC (ELECTROLYTE INJECTION CUP) OVERFLOW. CUSTOMER WAS NOT ALERTED TO ANY INSTRUMENT FLAGS OR ERROR MESSAGES PRIOR TO OBSERVING THE LEAK. A CUSTOMER TECHNICAL SUPPORT (CTS) ASSISTED THE CUSTOMER WITH PULLING THE EIC APART, BLOWING AIR THROUGH THE PORTS AND REASSEMBLY. HOWEVER, THE FLOODING WAS STILL OBSERVED. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE), CONSISTING OF GLOVES AND EYE PROTECTION WHEN THE LEAK WAS DISCOVERED. NO EXPOSURE OR INJURY OCCURRED TO THE LABORATORY PERSONNEL DUE TO THE LEAK. THE LABORATORY DOES HAVE AN EMERGENCY CHEMICAL SPILL PLAN IN PLACE. THE MATERIAL SAFETY DATA SHEETS (MSDS) WERE NOT CONSULTED IN THIS CASE; HOWEVER, THE CUSTOMER DOES HAVE ACCESS TO THE MSDS. THE CONTROLS WERE WITHIN RANGE AT THE BEGINNING OF THE SHIFT. NO ERRONEOUS RESULTS WERE GENERATED OR REPORTED OUT OF THE LAB IN CONNECTION TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58024 UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER DXC 800 PRO NA

    Patients

    Seq Age Sex Outcome Treatment
    1