BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 800 SYNCHRON SYSTEM

    MDR report key: 3915066 · Received July 6, 2014

    Report

    Report Number
    2050012-2014-00330
    Event Type
    Malfunction
    Date Received
    July 6, 2014
    Date of Event
    June 11, 2014
    Report Date
    June 11, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER (BEC) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE INSTRUMENT. THE FSE DETERMINED TUBE NUMBER 27 WAS LOOSE WHERE THE FITTING ATTACHES TO THE RATIO PUMP AND THE TUBE DISCONNECTED. THE FSE REPLACED THE TUBE TO CORRECT THE PROBLEM. THE FSE DID NOT FIND A PROBLEM WITH LINE 24 AS THE CUSTOMER INITIALLY REPORTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BECKMAN COULTER (BEC) HOTLINE SUPPORT THAT THEIR UNICEL DXC 800 SYNCHRON SYSTEM LEAKED FROM LINE 24 WHEN IT DISCONNECTED FROM THE ION SELECTIVE ELECTRODE (ISE) RATIO PUMP. THE CUSTOMER ALLEGED ERRONEOUS RESULTS WERE GENERATED INVOLVING THE SODIUM, POTASSIUM AND CARBON DIOXIDE ANALYTES DUE TO THE ISSUE. THE CUSTOMER ALSO REPORTED THAT SOME SODIUM AND CARBON DIOXIDE (CO2) RESULTS WERE SUPPRESSED. THERE WAS NO CHANGE OR EFFECT TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT REPORTED TO BEC. THE LEAK WAS CONTAINED TO THE INSTRUMENT AND THE OPERATOR WORE A LABORATORY COAT AND GLOVES WHILE OPERATING THE INSTRUMENT. PATIENT DATA WAS REQUESTED FROM THE CUSTOMER; THE CUSTOMER PROVIDED THE INITIAL PATIENT RESULTS ALLEGED TO BE ERRONEOUS BY THE CUSTOMER AND NOT THE RERUN DATA. BEC IS UNABLE TO VERIFY ERRONEOUS RESULTS, HOWEVER, VERY HIGH POTASSIUM, HIGH CHLORIDE AND VERY LOW CALCIUM RESULTS WERE VERIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    393046 UNICEL DXC 800 SYNCHRON SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR