BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXH 800 COULTER® CELLULAR ANALYSIS SYSTEM

    MDR report key: 3141263 · Received June 3, 2013

    Report

    Report Number
    1061932-2013-00953
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Date of Event
    May 6, 2013
    Report Date
    May 6, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K081930
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE. THE FSE INSPECTED THE INSTRUMENT AND FOUND THE TUBING FROM THE ASPIRATION PROBE TO BLOOD SAMPLING VALVE (BSV) CAME OFF OF PORT #1 ON BSV. THE FSE DRESSED THE TUBING AND REPLACED ON FITTING RESOLVING THE LEAK. WHILE ON SITE, THE FSE DISCOVERED THAT VALVE (VL100), FOR BSV SELF-CLEANING, WAS NOT CLOSING PROPERLY. THE FSE REPLACED THE VL100 ALLOWING DILUENT TO FLOW INTO THE WASTE CHAMBER. ACTIVITY PERFORMED WAS VERIFIED TO MEET THE SPECIFIED REQUIREMENTS PER ESTABLISHED PROCEDURES. FAILURE MODE OF THE LEAK WAS RELATED TO A DISCONNECTED TUBING FROM PORT 1 ON THE BSV. FAILURE MODE OF AN INSUFFICIENT DILUENT GOING TO THE WASTE CHAMBER WAS ASSOCIATED WITH THE VL100 NOT CLOSING PROPERLY. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BECKMAN COULTER (BEC) THAT AN UNKNOWN AMOUNT OF BLUE LIQUID WAS LEAKING FROM THE UNICEL DXH 800 COULTER ANALYZER AND ONTO THE COUNTER. THE LEAK WAS NOT CONTAINED WITHIN THE INSTRUMENT. THE MATERIAL SAFETY DATA SHEET (MSDS) WAS NOT REVIEWED BY THE CUSTOMER. THERE IS AN EXPOSURE CONTROL/RISK MANAGEMENT PLAN IN PLACE AT THE FACILITY. THE OPERATOR WAS WEARING A LABORATORY COAT, GLOVES AND EYEWEAR AT THE TIME OF THE INCIDENT. THERE WAS NO BIOHAZARD EXPOSURE TO OPEN WOUNDS OR MUCOUS MEMBRANES. THE OPERATOR DID NOT SEEK MEDICAL ATTENTION. THERE WAS NO IMPACT TO PATIENT RESULTS. NO DEATH OR INJURY IS ATTRIBUTED TO THIS EVENT AND THERE WAS NO CHANGE TO PATIENT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244044 UNICEL® DXH 800 COULTER® CELLULAR ANALYSIS SYSTEM COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER DXH 800 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1