BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXH 800 COULTER® CELLULAR ANALYSIS SYSTEM

    MDR report key: 2521970 · Received April 6, 2012

    Report

    Report Number
    1061932-2012-01137
    Event Type
    Malfunction
    Date Received
    April 6, 2012
    Date of Event
    March 10, 2012
    Report Date
    March 10, 2012
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    GKZ
    PMA / PMN Number
    K081930
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WENT ON-SITE AND CHECKED THE WASTE SYSTEM AND VERIFIED THAT WASTE LEVEL SENSORS WERE OPERATING CORRECTLY AND THAT THE UNIT GOES OFFLINE WHEN BOTH CONTAINERS ARE FULL. HOWEVER, IT IS THE LABORATORY PRACTICE FOR THIS CUSTOMER TO EMPTY THE WASTE CONTAINERS TWICE A DAY BEFORE THEY ARE FULL. PER BEC LABELING, DXH 800 INSTRUCTIONS FOR USE: WASTE CONTAINERS (IF USED) MUST BE LOCATED IN A SAFE PLACE AND TUBING CONNECTION INTEGRITY MUST BE VERIFIED PERIODICALLY. OPERATOR MUST NOT REPLACE THE WASTE CONTAINER WHILE THE SPM IS CYCLING. POSSIBLE BIOHAZARDOUS CONDITION. THE CONTENTS OF THE OLD WASTE CONTAINER AND ITS ASSOCIATED TUBING CAN INCLUDE RESIDUAL BIOLOGICAL MATERIAL AND MUST BE HANDLED WITH CARE. CHECK THE TUBING CONNECTION AND CONTAINER LOCATION PERIODICALLY. AVOID SKIN CONTACT AND CLEAN UP SPILLS IMMEDIATELY. DISPOSE OF THE CONTENTS OF THE WASTE CONTAINER IN ACCORDANCE WITH YOUR LOCAL REGULATIONS AND ACCEPTABLE LABORATORY PROCEDURES. THE CAUSE OF THE WASTE SPRAY IS THE INSTRUMENT STARTED TO CYCLE WHILE THE CUSTOMER HAD THE WASTE TUBE ASSEMBLY OUT OF THE WASTE CONTAINER. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) STATING THAT AS SHE REMOVED THE WASTE TUBE/LEVEL SENSE ASSEMBLY CAP AND STRAW FROM THE WASTE CONTAINER ON THEIR UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM, APPROXIMATELY 10 ML OF PALE PINK WASTE FLUID WAS SPRAYED ON THE FLOOR AND SOME ON THE LOWER PART OF HER LAB COAT AND CLOTHING (PERSONAL PROTECTIVE EQUIPMENT CONSISTING OF GLOVES AND A LAB COAT WAS WORN AT THE TIME OF THE EVENT) THERE WAS NO EXPOSURE TO THE EYES OR MUCOUS MEMBRANES AND MEDICAL ATTENTION WAS NOT SOUGHT. THERE WAS NO INJURY REPORTED AND THERE WAS NO AFFECT TO PATIENT SAMPLES. AS A PREVENTATIVE MEASURE, A WARNING SIGN WAS PLACED ON THE UNIT AND AN EMAIL SENT TO ALL OPERATORS TO PUT THE INSTRUMENT OFFLINE BEFORE EMPTYING WASTE CONTAINERS. A SERVICE VISIT WAS SET UP TO CHECK THE CYCLING OF THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXH 800 COULTER® CELLULAR ANALYSIS SYSTEM AUTOMATED DIFFERENTIAL CELL COUNTER GKZ BECKMAN COULTER INC. DXH 800 NA

    Patients

    Seq Age Sex Outcome Treatment
    1