BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 SYNCHRON® SYSTEM

    MDR report key: 2853614 · Received December 3, 2012

    Report

    Report Number
    2050012-2012-01897
    Event Type
    Malfunction
    Date Received
    December 3, 2012
    Date of Event
    November 4, 2012
    Report Date
    November 5, 2012
    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

    THE FIELD SERVICE ENGINEER (FSE) DISCOVERED CHLORIDE (CL) PORT OF THE FLOWCELL WAS COMPLETELY FILLED WITH BUILDUP AND NOT CLEANED AS PER BECKMAN COULTER RECOMMENDED MAINTENANCE. THE FSE CLEANED THE PORT BUT IT DID NOT RESOLVE THE ISSUE. THE FSE OBSERVED CONTAMINATION IN THE FLOWCELL AND BUBBLES IN THE RATIO PUMP AND DECONTAMINATED THE SYSTEM AND PERFORMED ROUTINE YEARLY PREVENTIVE MAINTENANCE WHICH INCLUDED REPLACING THE RATIO PUMP. THE FSE REPLACED THE POTASSIUM (K) AND CALCIUM (CA) ELECTRODE TIPS AS WELL AS THE SODIUM (NA) ELECTRODE. SERVICE ACTIVITY PERFORMED WAS VERIFIED TO MEET THE SPECIFIED REQUIREMENTS PER ESTABLISHED PROCEDURES. THE INSTRUMENT CONFORMED TO THE MANUFACTURER'S PUBLISHED PERFORMANCE SPECIFICATIONS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED ERRONEOUS SODIUM (NA), POTASSIUM (K), AND CARBON DIOXIDE (CO2) RESULTS, FOR MULTIPLE PATIENTS, INVOLVING THE UNICEL DXC 800 SYNCHRON SYSTEM. THE CUSTOMER STATED THE ERRONEOUS RESULTS WERE RELEASED OUT OF THE LABORATORY AND QUESTIONED BY THE PHYSICIAN. AMENDED REPORTS WERE ISSUED IMMEDIATELY TO THE PHYSICIAN. THE CUSTOMER STATED IT IS UNKNOWN IF PATIENT TREATMENT WAS IMPACTED. THERE HAS BEEN NO REPORT OF PATIENT CONSEQUENCE ASSOCIATED WITH THIS EVENT. 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 800 SYNCHRON® SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1