BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM

    MDR report key: 2449355 · Received February 14, 2012

    Report

    Report Number
    1061932-2012-00498
    Event Type
    Malfunction
    Date Received
    February 14, 2012
    Date of Event
    January 18, 2012
    Report Date
    January 18, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K081930
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE ROOT CAUSE OF THE LEAK WAS A CLOG IN THE RETIC MIXING CHAMBER, WHICH WAS RESOLVED WITH THE SERVICES PERFORMED BY THE FSE. (NOTE: THE BECKMAN COULTER, INC. IDENTIFIER FOR THIS REPORT IS (B)(4).)

    Description of Event or Problem · 1

    CUSTOMER CALLED TO REPORT A LEAK AT THE FRONT OF THE UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM, BUT COULD NOT LOCATE THE SOURCE OF THE LEAK. CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF A LABORATORY COAT AND GLOVES. CUSTOMER DID NOT COME IN CONTACT WITH THE FLUID, AND MEDICAL ATTENTION WAS NOT SOUGHT. THERE WAS NO REPORT OF EXPOSURE TO MUCOUS MEMBRANES OR OPEN WOUNDS, AND NO ONE WAS SPLASHED OR SPRAYED. THERE WAS NO DEATH, INJURY OR CHANGE TO PATIENT TREATMENT ATTRIBUTED TO OR ASSOCIATED WITH THIS COMPLAINT. THERE WAS NO IMPACT TO PATIENT SAMPLES OR RESULTS. THE FIELD SERVICE ENGINEER (FSE) INSPECTED THE INSTRUMENT AND FOUND THAT THE RETICULOCYTE (RETIC) MIXING CHAMBER WASTE LINE WAS OBSTRUCTED WITH A CLOG, PREVENTING IT FROM DRAINING. THE FSE UNCLOGGED THE LINE, AFTER WHICH THERE WAS NO FURTHER EVIDENCE OF LEAKING. THE REPAIRS WERE VERIFIED PER ESTABLISHED PROCEDURES, AND THE RESULTS MET PUBLISHED PERFORMANCE SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER, INC. DXH 800

    Patients

    Seq Age Sex Outcome Treatment
    1