BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON CX5 DELTA CLINICAL SYSTEM

    MDR report key: 2724134 · Received September 3, 2012

    Report

    Report Number
    2050012-2012-01435
    Event Type
    Malfunction
    Date Received
    September 3, 2012
    Date of Event
    August 9, 2012
    Report Date
    August 9, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K950958
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) THAT THE ELECTROLYTE INJECTION CUP (EIC) OF THE SYNCHRON CX 5 DELTA CLINICAL SYSTEM STOPPED DRAINING PROPERLY, STARTED OVERFILLING AND LEAKING INTO THE ION SELECTIVE ELECTRODE (ISE) ASSEMBLY. CUSTOMER REPORTED THE LEAK WAS CONTAINED TO THE INSTRUMENT. CUSTOMER INDICATED THE LEAKAGE CONSISTED OF DE-IONIZED WATER AND ISE BUFFER REAGENT. CUSTOMER INDICATED HE WAS WEARING GLOVES AND LAB COAT WHEN HE CLEANED UP THE LEAKAGE IN THE TOP PORTION OF THE ISE ASSEMBLY. CUSTOMER REPORTED THAT ERRONEOUS RESULTS WERE NOT GENERATED. THERE WAS NO REPORT OF ANY ADVERSE EVENT OR INJURY REQUIRING MEDICAL INTERVENTION OR PATIENT TREATMENT. BEC CUSTOMER TECHNICAL SPECIALIST (CTS) TROUBLESHOT THE ISSUE WITH THE CUSTOMER VIA THE TELEPHONE. CUSTOMER REPORTED LINE #13 OF THE EIC HAD DISCONNECTED. CTS INSTRUCTED THE CUSTOMER TO REMOVE THE TUBING AND CUSTOMER FOUND A SMALL OBSTRUCTION IN THE EIC WITH THE CTS' ASSISTANCE. CUSTOMER INDICATED HE WAS ABLE TO REMOVE THE OBSTRUCTION. CTS ASSISTED THE CUSTOMER WITH REINSTALLING THE TUBING TO THE EIC AND REINSERTING THE EIC ON THE ISE ASSEMBLY. CUSTOMER PRIMED THE ISE AND THE EIC FILLED AND DRAINED PROPERLY.

    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. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1