BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXH 800 COULTER® CELLULAR ANALYSIS SYSTEM

    MDR report key: 2217972 · Received August 19, 2011

    Report

    Report Number
    1061932-2011-01192
    Event Type
    Malfunction
    Date Received
    August 19, 2011
    Date of Event
    July 21, 2011
    Report Date
    July 21, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K081930
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER DID NOT REQUEST ANY SERVICE BECAUSE THE WASTE CONTAINER WAS FUNCTIONAL. THE CUSTOMER CALLED BACK THE NEXT DAY AND REPORTED THAT THE SENSORS FOR WASTE CONTAINER # 1 AND CONTAINER # 2 WERE NOT WORKING. A FIELD SERVICE ENGINEER (FSE) SENT THE CUSTOMER TWO NEW PICK-UP TUBES FOR BOTH WASTE CONTAINERS. SINCE THE CUSTOMER INSTALLED THE TWO NEW WASTE PICKUP TUBES, THEY HAVE NOT HAD ANYMORE SPILLS. ROOT CAUSE FOR THE SPILL WAS ATTRIBUTED TO OPERATOR ERROR. BEC IDENTIFIER FOR THIS REPORT IS (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) THAT THE WASTE CONTAINER # 1 OF THEIR UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM HAD OVERFLOWED BECAUSE THE LAB TECHNICIAN DID NOT PROPERLY CLOSE THE WASTE PICK UP TUBE ASSEMBLY THAT CONNECTS TO THE OVERFLOW SENSOR. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF LAB COAT, GLOVES AND SAFETY GOGGLES AT THE TIME OF THE EVENT. THE CUSTOMER CLEANED UP THE SPILL AND RESUMED OPERATION. NO INJURIES OCCURRED AND MEDICAL ATTENTION WAS NOT SOUGHT. THERE WAS NO REPORT OF EXPOSURE TO MUCOUS MEMBRANES OR OPEN WOUNDS. THERE WAS NO DEATH, INJURY OR CHANGE TO PATIENT TREATMENT ATTRIBUTED OR CONNECTED WITH THIS EVENT.

    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