BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXH 800 COULTER® CELLULAR ANALYSIS SYSTEM

    MDR report key: 2598583 · Received June 5, 2012

    Report

    Report Number
    1061932-2012-01812
    Event Type
    Malfunction
    Date Received
    June 5, 2012
    Date of Event
    May 10, 2012
    Report Date
    May 10, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K081930
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE MODE - THE CAUSE OF THE LEAK IS THE TUBES ON QD421 AND QD422 WERE SWITCHED. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED CLEAR LIQUID ON THE TOPS OF TUBES AND DRIPPING OFF THE SAMPLE PROBE ON THE UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM. THE LEAK WAS >1 ML AND WAS CONTAINED WITHIN THE INSTRUMENT. 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. THE OPERATOR OBSERVED THE LEAK WHILE PERFORMING MAINTENANCE; HENCE PATIENT RESULTS WERE NOT AFFECTED. ON (B)(4) 2012, A FIELD SERVICE ENGINEER (FES) FOUND THAT QUICK DISCONNECT (QD)421 AND QD422 WERE SWITCHED ON THE SAMPLE ASPIRATION MODULE (SAM). THE TUBES WERE PUT ON THE PROPER FITTINGS, DAILY CHECKS AND CONTROLS RUN, AND INSTRUMENT RETURNED BACK TO THE CUSTOMER. SERVICE MODIFICATION (MOD) 11005 FOR THE PROBE WASH TUBING ROUTING IMPROVEMENT HAD BEEN COMPLETED ON (B)(4) 2012. THIS MOD REQUIRES REPLACEMENT OF THE PROBE WASH TUBING BETWEEN THE WASH COLLAR AND QD421 AND QD422. PER FSE STATEMENT ON (B)(4) 2012, THE TUBES WERE PROBABLY PUT ON INCORRECTLY DURING THE SERVICE MOD AND THE SWITCH TOOK A FEW WEEKS TO CAUSE ANY NOTICEABLE PROBLEMS. THE DRIPPING WAS FROM THE PROBE BECAUSE IT WASN'T RECEIVING THE PROPER SUCTION. THE LEAK MORE THAN LIKELY DID NOT CAUSE ANY CARRYOVER BECAUSE THE CUSTOMER STATED THAT THE INSTRUMENT WAS WORKING FINE AND THEY DID A COMPARISON WITH THEIR OTHER INSTRUMENT AND THE RESULTS WERE SIMILAR. THE PROBE MAY HAVE THE PRESENCE OF BLOOD, BODY FLUIDS, 6C CELL CONTROL, RETIC-X CELL CONTROL, BODY FLUID CELL CONTROL AND DILUENT DURING NORMAL OPERATION, AND DXH CLEANER DURING SHUTDOWN. NO DISCREPANT RESULTS WERE GENERATED; HOWEVER, A FAILURE MODE WAS IDENTIFIED THAT HAS THE POTENTIAL TO CAUSE DISCREPANT RESULTS FOR ANY PARAMETER DUE TO OPEN VIAL SAMPLE CONTAMINATION.

    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 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1