BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM

    MDR report key: 2233736 · Received September 3, 2011

    Report

    Report Number
    2050012-2011-05024
    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
    K060256
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS DISPATCHED TO THE SITE ON (B)(4) 2011 FOR THIS EVENT. THE FIELD SERVICE ENGINEER (FSE) REPLACED THE WASH SYRINGE AND PERIPUMP TUBING. INSTRUMENT PERFORMANCE WAS CONFIRMED PER ESTABLISHED PROCEDURE. THE INSTRUMENT WAS RETURNED INTO SERVICE AFTER THE COMPLETION OF THE NECESSARY REPAIRS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT ON (B)(6) 2011 A LEAK WAS OBSERVED ON AN UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM. THE LEAK APPEARED TO BE COMING FROM THE WASH AND SAMPLE SYRINGE. THERE WAS NO BIOHAZARDOUS EXPOSURE TO HEALTHCARE WORKER UNCOVERED WOUNDS OR MUCOUS MEMBRANES AND NO INJURIES WERE REPORTED. NO HEALTHCARE WORKER SOUGHT 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. THERE WAS AN EXPOSURE PLAN IN PLACE AT THE FACILITY AND THE MATERIAL SAFETY DATA SHEET WAS AVAILABLE AT THE FACILITY. THE CUSTOMER TIGHTENED BOTH SYRINGES AS A TROUBLESHOOTING MEASURE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1