BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM

    MDR report key: 2252520 · Received September 17, 2011

    Report

    Report Number
    2050012-2011-05593
    Event Type
    Malfunction
    Date Received
    September 17, 2011
    Date of Event
    August 18, 2011
    Report Date
    August 18, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K060256
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BEC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON (B)(4) 2011 AND OBSERVED OVERFLOW FROM THE EIC. THE FSE REMOVED AN OBSTRUCTION FROM THE WASTE PORT OF THE EIC. REPAIRS WERE VERIFIED PER ESTABLISHED PROCEDURES PRIOR TO RETURNING THE INSTRUMENT INTO SERVICE. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) REPORTING THAT THE ELECTROLYTE INJECTION CUP (EIC) WAS NOT DRAINING IN THE UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM. CUSTOMER HAD CLEANED THE EIC AND WAS GOING TO PERFORM THE TWICE WEEKLY MAINTENANCE PROCEDURE DUE TO SODIUM (NA) LOW ANION GAPS FOR 5-6 PATIENTS. CUSTOMER STATED THAT NO ERRONEOUS RESULTS WERE GENERATED. NO OPERATOR EXPOSURE WAS NOTED FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER INC. DXC 600I N/A

    Patients

    Seq Age Sex Outcome Treatment
    1