BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM

    MDR report key: 3982398 · Received August 6, 2014

    Report

    Report Number
    1061932-2014-01821
    Event Type
    Malfunction
    Date Received
    August 6, 2014
    Date of Event
    July 11, 2014
    Report Date
    July 11, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K081930
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) OBSERVED THE QUICK DISCONNECT (QD284) BETWEEN THE FLOW CELL TUBING HARNESS NUMBER 8 AND VL211 HAD BECOME LOOSE AND WAS SLIGHTLY LEAKING DILUENT. THE FSE RETIGHTENED THE QUICK DISCONNECT, RESOLVING THE REPORTED EVENT. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A CONTAINED LEAK ON THE UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM; AND THERE WERE 'R' FLAGS RECOVERED ON RETIC CONTROLS. THE VOLUME OF THE LEAK IS UNKNOWN. THE CUSTOMER PERFORMED CLEANING PROCEDURE WITH HELP FROM THE CUSTOMER TECHNICAL SPECIALIST (CTS) OVER THE PHONE. THE CUSTOMER CLEANED THE FLOW CELL, BUT THE ISSUE WAS NOT RESOLVED. THERE WAS NO REPORTED EXPOSURE TO MUCOUS MEMBRANES OR OPEN WOUNDS. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF GLOVES AND A LAB COAT AT THE TIME OF THE OCCURRENCE. NO ERRONEOUS PATIENT RESULTS WERE GENERATED IN CONNECTION WITH THIS EVENT. THERE WAS NO DEATH, INJURY, OR AFFECT TO USER OR TO PATIENT TREATMENT ATTRIBUTED TO THIS EVENT. A BECKMAN COULTER (BEC) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ASSESS THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460653 UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1