BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 SYNCHRON® SYSTEM

    MDR report key: 2233757 · Received September 3, 2011

    Report

    Report Number
    2050012-2011-05025
    Event Type
    Malfunction
    Date Received
    September 3, 2011
    Date of Event
    August 5, 2011
    Report Date
    August 5, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS DISPATCHED TO THE SITE TO ADDRESS THE ISSUE. THE FIELD SERVICE ENGINEER (FSE) DETERMINED THE INSTRUMENT HAD BEEN LEAKING WATER FROM THE 10 PSI (POUNDS/INCH2) VALVE. THE FSE VERIFIED FLOAT SWITCH OPERATION WHICH WAS FOUND TO BE OPERATING NORMALLY. THE INSTRUMENT HYDROPNEUMATIC SYSTEM WAS INSPECTED AND NO PROBLEMS WERE NOTED. THE FSE REMOVED LINES TO THE DEIONIZED WATER TANK AND ACTUATED VALVES TO CLEAR LINES. THE LOW PRESSURE REGULATOR WAS ADJUSTED TO A LOWER PRESSURE, AND THE LOCK NUT WAS TIGHTENED. THE INSTRUMENT WAS PRIMED FIFTY TIMES WITH NO INSTRUMENT ERRORS OR LEAKS OBSERVED. THE CUSTOMER TESTED SAMPLES WITH NO ERRORS PRODUCED. THE INSTRUMENT PERFORMANCE WAS VERIFIED PER ESTABLISHED PROCEDURES, AND WAS SUBSEQUENTLY RETURNED INTO SERVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT ON (B)(6) 2011 A LEAK WAS OBSERVED ON AN UNICEL DXC 600 SYNCHRON SYSTEM. THE LEAK WAS BELIEVE TO BE A WATER LEAK AND APPEARED TO BE COMING FROM THE LOW PRESSURE REGULATOR. THE CUSTOMER STATED THE DEIONIZED WATER CANISTER WAS COMPLETELY FULL OF WATER. THE INSTRUMENT GENERATED "HYDRO SMART MODULE NOT COMMUNICATING" ERRORS. THERE WAS NO BIOHAZARDOUS EXPOSURE TO HEALTHCARE WORKER UNCOVERED WOUNDS OR MUCOUS MEMBRANES AND NO INJURIES WERE REPORTED. NO PERSONNEL SOUGHT ANY MEDICAL ATTENTION IN ASSOCIATION WITH THIS EVENT. NO PATIENT RESULTS WERE AFFECTED BY THIS EVENT. NO DEATH, INJURY OR MODIFICATION TO PATIENT TREATMENT WAS ASSOCIATED WITH THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1