BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 PRO SYNCHRON® CLINICAL SYSTEM

    MDR report key: 2221891 · Received August 24, 2011

    Report

    Report Number
    2050012-2011-04740
    Event Type
    Malfunction
    Date Received
    August 24, 2011
    Date of Event
    January 27, 2011
    Report Date
    January 27, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER WAS ON-SITE AND REBUILT VACUUM PUMPS, REPLACED CC WASH COLLAR AND CC VACUUM VALVE AND CHECKED FLUID FLOW WHEN IT WAS NOTED THAT WASH COLLAR SPLATTERING WAS STILL PRESENT. FSE ORDERED MORE PARTS AND WENT BACK ON-SITE THE FOLLOWING WEEK. FSE REPLACED CC CRANE VACUUM LINE, SWAPPED CC AND MC (MODULAR CHEMISTRY) WASH COLLAR SOLENIODS, ADJUSTED LOW PRESSURE TO 8.5 PSI, REPLACED BENT SAMPLE MIXER PADDLE AND PERFORMED ALIGNMENT. FSE THEN VERIFIED OPERATION WITH CALIBRATION AND QC WHICH MET SPECIFICATIONS. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) STATING FLUID WAS NOTICED IN THE DRIP WELL FOR THE CARTRIDGE CHEMISTRY (CC) SAMPLE PROBE (ON THE SAMPLE WHEEL COVER) IN THE UNICEL DXC 600 PRO SYNCHRON® CLINICAL SYSTEM. PER CUSTOMER, THE LEAK APPEARED TO BE DI (DEIONIZED) WATER. NO INJURY WAS REPORTED AND NO ERRONEOUS RESULTS WERE GENERATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 600 PRO SYNCHRON® CLINICAL SYSTEM CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. DXC 600 PRO NA

    Patients

    Seq Age Sex Outcome Treatment
    1