BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON CX PRO CLINICAL SYSTEMS, MODEL CX9 PRO

    MDR report key: 2254186 · Received September 19, 2011

    Report

    Report Number
    2050012-2011-05423
    Event Type
    Malfunction
    Date Received
    September 19, 2011
    Date of Event
    August 21, 2011
    Report Date
    August 21, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K011465
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS SUSPECTED THAT USER ERROR DURING MAINTENANCE CONTRIBUTED TO THE PRODUCT PROBLEM. THE CUSTOMER STATED THAT THE OVERFILLING EIC PROBLEM OCCURRED AFTER MAINTENANCE AND THE EIC WAS NOT PROPERLY EMPTYING BECAUSE OF THE REVERSED PERIPUMP. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER CALLED TO REPORT THE OVERFILLING OF THE ELECTROLYTE INJECTION CUP (EIC) ON THE CX9 ALX CLINICAL CHEMISTRY ANALYZER. CUSTOMER STATED THAT NO ERRONEOUS RESULTS WERE REPORTED. CUSTOMER STATED THAT THE PRODUCT PROBLEM STARTED AFTER PERFORMING MAINTENANCE ON THE INSTRUMENT. THE CUSTOMER TECHNICAL SPECIALIST (CTS) ASKED THE CUSTOMER TO CHECK THE EIC DRAIN PERIPUMP. THROUGH TROUBLESHOOTING, THE TUBING TO THE PUMP WAS FOUND TO BE REVERSED, THEREBY PREVENTING THE EIC CUP FROM PROPERLY EMPTYING ITS CONTENTS. THE CTS THEN INSTRUCTED THE CUSTOMER AS TO HOW TO RESOLVE THIS ISSUE, ALLOWING THE CUSTOMER TO PROPERLY CALIBRATE ON THE INSTRUMENT. NEITHER THE USER NOR ANY PATIENTS WERE HARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON CX PRO CLINICAL SYSTEMS, MODEL CX9 PRO ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER, INC. CX9 ALX

    Patients

    Seq Age Sex Outcome Treatment
    1