BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXH 800 COULTER® CELLULAR ANALYSIS SYSTEM

    MDR report key: 2559254 · Received May 3, 2012

    Report

    Report Number
    1061932-2012-01405
    Event Type
    Malfunction
    Date Received
    May 3, 2012
    Date of Event
    April 9, 2012
    Report Date
    April 9, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKJ
    PMA / PMN Number
    K081930
    Removal / Correction Number
    2050012-04/05/2012-006C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE LEAK WAS CONTAINED WITHIN THE INSTRUMENT. THE CUSTOMER STATED THE PUDDLE WAS 6 INCHES LONG HOWEVER, HE WAS UNABLE TO DETERMINE THE QUANTITY.

    Additional Manufacturer Narrative · 1

    THE CAUSE OF THE LEAK WAS A PLUGGED NRBC MIX CHAMBER. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A LEAK OF APPROXIMATELY 4 ML OF BLOODY FLUID THAT WAS CONTAINED IN THE AIR MIX TEMPERATURE CONTROL (AMTC) MODULE OVERFLOW TRAY ON THE UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM. THE LEAK WAS CONTAINED WITHIN THE INSTRUMENT. THE CUSTOMER STATED THE PUDDLE WAS 6 INCHES LONG, HOWEVER, HE WAS UNABLE TO DETERMINE THE QUANTITY. THE OPERATOR WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF GLOVES, EYE PROTECTION, AND LAB COAT AT THE TIME OF THE INCIDENT. PATIENT SAMPLES OR RESULTS WERE NOT REPORTED TO HAVE BEEN AFFECTED BY THE LEAK. NO INJURIES OCCURRED AND MEDICAL ATTENTION WAS NOT SOUGHT. THE CUSTOMER DID NOT REPORT EXPOSURE (SPLASHED OR SPRAYED) TO MUCOUS MEMBRANES OR OPEN WOUNDS. THE CUSTOMER DID NOT REVIEW THE MSDS, HOWEVER, THE FACILITY DOES HAVE AN EXPOSURE CONTROL / RISK MANAGEMENT PLAN IN PLACE. ON THE DAY OF THE EVENT, A FIELD SERVICE ENGINEER (FSE) FOUND DEBRIS LODGED IN THE NRBC MIX CHAMBER. THE DEBRIS WAS RUBBER FROM THE SPECIMEN TUBE STOPPER. THE DEBRIS PREVENTED THE CHAMBER FROM DRAINING, WHICH CAUSED IT TO OVERFLOW INTO OVERFLOW TRAY UNDERNEATH THE AMTC MODULE. THE FSE REMOVED THE DEBRIS FROM THE CHAMBER TO CORRECT THE ISSUE. BLOOD, 6C CELL CONTROL, DILUENT, AND DXH CELL LYSE MAY BE PRESENT IN THE NRBC MIX CHAMBER DURING NORMAL OPERATION, AND DXH CLEANER DURING SHUTDOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXH 800 COULTER® CELLULAR ANALYSIS SYSTEM SPINNER, SLIDE, AUTOMATED GKJ BECKMAN COULTER, INC. DXH 800 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1