BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON® CX5 DELTA CLINICAL SYSTEM

    MDR report key: 2242356 · Received September 10, 2011

    Report

    Report Number
    2050012-2011-05055
    Event Type
    Malfunction
    Date Received
    September 10, 2011
    Date of Event
    August 11, 2011
    Report Date
    August 11, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K950958
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BEC CUSTOMER TECHNICAL SPECIALIST (CTS) HAD THE CUSTOMER TO SHUTDOWN THE HYDROPNEUMATIC AND TO CHECK THE GRAVITY DRAIN LINE FOR THE SAMPLE WASH CUP. THE VENT LINE IS WHERE THE DILUTED WASH AND WATER HAVE LEAKED FROM. THE VENT LINE HAS NO FILTER ON IT. THE CTS HAD THE CUSTOMER CHECK THE WASTE BUCKET. THERE WAS A CLOG IN THE WASTE BUCKET. THE CTS HAD THE CUSTOMER CLEAR THE CLOG, EMPTY THE WASTE AND CLEAN UP THE WASTE BUCKET AND FLOAT. SERVICE WAS NOT DISPATCHED FOR THIS EVENT. THERE HAD BEEN NO FURTHER LEAK COMPLAINT FILED BY THE CUSTOMER AS OF (B)(4) 2011. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) THAT SYNCHRON CX5 DELTA CLINICAL SYSTEM WAS LEAKING FLUID. THE CUSTOMER STATED THAT THE SAMPLE WASH CUP WAS SPRAYING WASH SOLUTION AND WATER AND ALSO LEAKING DOWN INTO THE HYDROPNEUMATIC AREA. THE CUSTOMER INDICATED THAT THE INSTRUMENT WAS BEING USED FOR A CORRELATION STUDY AND NO ERRONEOUS PATIENT RESULTS HAD BEEN GENERATED. THE CUSTOMER WAS WEARING GLOVES, LAB COAT, AND EYE PROTECTION. MSDS WAS NOT REVIEWED, BUT THE FACILITY HAS AN EXPOSURE CONTROL PLAN. THE OPERATOR DID NOT SEEK MEDICAL ATTENTION AND THERE WAS NO EFFECT TO PATIENT OR USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON® CX5 DELTA CLINICAL SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER, INC. CX5 DELTA NA

    Patients

    Seq Age Sex Outcome Treatment
    1