BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 SYNCHRON® SYSTEM

    MDR report key: 2233752 · Received September 3, 2011

    Report

    Report Number
    2050012-2011-04763
    Event Type
    Malfunction
    Date Received
    September 3, 2011
    Date of Event
    August 4, 2011
    Report Date
    August 4, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS DISPATCHED TO THE SITE ON (B)(6) 2011 FOR THIS EVENT. THE FIELD SERVICE ENGINEER (FSE) REMOVED THE ENTIRE (ISE) ION-SELECTIVE ELECTRODE BLOCK AND FLUSHED/CLEANED THE UNIT. THE FSE FOUND AN EXTRA CLEAR CARBON DIOXIDE MEMBRANE WHILE CLEANING THE ISE. THE MEMBRANE WAS REMOVED AND A NEW ONE WAS INSTALLED. THE INSTRUMENT WAS RETURNED INTO SERVICE AFTER THE REPAIRS WERE SUCCESSFULLY COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT ON (B)(6) 2011 ERRONEOUS/SUPPRESSED SODIUM, POTASSIUM, CHLORIDE, CARBON DIOXIDE (CO2) AND/OR CALCIUM RESULTS WERE GENERATED FROM A UNICEL DXC 600 SYNCHRON SYSTEM FOR THREE PATIENTS. THE ERRONEOUS/SUPPRESSED RESULTS WERE NOT RELEASED FROM THE LABORATORY. DURING EVENT TROUBLESHOOTING THE CUSTOMER IDENTIFIED THAT THE INSTRUMENT LINE 25 HAD DETACHED FROM THE FLOW CELL AND WAS LEAKING. THIS WAS THE CAUSE OF THE ERRONEOUS AND SUPPRESSED RESULTS. THE HEALTHCARE WORKER RECONNECTED THE LINE. THE HEALTHCARE WORKER WORE PERSONAL PROTECTIVE EQUIPMENT WHILE INTERFACING WITH THE INSTRUMENT. 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 DEATH, INJURY OR MODIFICATION TO PATIENT TREATMENT WAS ASSOCIATED WITH THIS EVENT. THERE WAS AN EXPOSURE PLAN IN PLACE AT THE FACILITY AND THE MATERIAL SAFETY DATA SHEET WAS UTILIZED BY THE FACILITY. THE SAMPLES WERE SERUM SAMPLES. NO ADDITIONAL SYSTEM INFORMATION OR SAMPLE COLLECTION/HANDLING INFORMATION WAS PROVIDED BY THE CUSTOMER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1