BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER HMX ANALYZER WITH AUTOLOADER

    MDR report key: 2597958 · Received June 4, 2012

    Report

    Report Number
    1061932-2012-01792
    Event Type
    Malfunction
    Date Received
    June 4, 2012
    Date of Event
    May 9, 2012
    Report Date
    May 9, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K010765
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) THAT FLUID LEAKED FROM THE COULTER HMX ANALYZER WITH AUTOLOADER (HMX) WHILE THEY WERE RUNNING 5C CELL CONTROLS. CUSTOMER REPORTED THAT HMX ANALYZER GAVE DILUENT COMPARISON OUT OF LIMITS ERROR. CUSTOMER REPORTED THAT THERE WAS A PUDDLE OF DILUENT BEHIND THE ANALYZER. CUSTOMER REPORTED THAT THE LEAKED FLUID WAS INSIDE THE BACK HALF OF THE RIGHT SIDE COMPARTMENT OF THE HMX ANALYZER. CUSTOMER REPORTED THAT THE VOLUME OF THE LEAK WAS LESS THAN 50 ML. CUSTOMER REPORTED THAT PATIENT RESULTS WERE NOT AFFECTED. THERE WAS NO REPORT OF ANY ADVERSE EVENT OR INJURY REQUIRING MEDICAL INTERVENTION OR PATIENT TREATMENT. BEC CUSTOMER TECHNICAL SUPPORT (CTS) TROUBLESHOT THE ISSUE WITH THE CUSTOMER VIA THE TELEPHONE. CUSTOMER REPORTED THAT THE LEAK WAS FROM THE BLUE-STRIPE PROPRIETARY PULL-APART TUBING THROUGH THE NORMALLY CLOSED PINCH VALVE (PV) 49. CTS GUIDED THE CUSTOMER THROUGH REPLACEMENT OF THE TUBING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER HMX ANALYZER WITH AUTOLOADER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1