BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM

    MDR report key: 2812825 · Received October 31, 2012

    Report

    Report Number
    2050012-2012-01802
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Date of Event
    October 3, 2012
    Report Date
    October 4, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K060256
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) DISCOVERED CORROSION ON THE WASH ASSEMBLY AND REPLACED THE WASH ASSEMBLY BUT DID NOT RESOLVE THE FLUID OVERFLOW ISSUE. THE FSE OBSERVED A CLOG IN THE WASTE LINE BEFORE THE Y-FITTING, AFTER THE PERISTALTIC PUMP. THE FSE REPLACED THE LINE TO THE FITTING AND VERIFIED SYSTEM PERFORMANCE. THE INSTRUMENT CONFORMED TO THE MANUFACTURER'S PUBLISHED PERFORMANCE SPECIFICATIONS. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A SMALL AMOUNT OF WASH BUFFER SOLUTION LEAKED FROM THE RIGHT SIDE CAP PIERCER WELL RESERVOIR INVOLVING THE UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM. THE CUSTOMER NOTED PARTIAL OBSTRUCTION IN THE Y-FITTING AT THE WASTE TUBING. THE FLUID WAS CONTAINED WITHIN THE INSTRUMENT AND CLEANED UP WITH PAPER TOWELS. THE CUSTOMER HAD ON PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF GLOVES AND A LABORATORY COAT AND DID NOT HAVE DIRECT CONTACT WITH THE FLUID. THERE WAS NO OPERATOR INJURY OR ADVERSE EFFECT ASSOCIATED WITH THIS EVENT. PATIENT RESULTS WERE NOT IMPACTED. THE CUSTOMER INDICATED QUALITY CONTROL (QC) WAS WITHIN SPECIFICATION. BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1