BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXH 800 COULTER® CELLULAR ANALYSIS SYSTEM

    MDR report key: 2242305 · Received September 10, 2011

    Report

    Report Number
    1061932-2011-01436
    Event Type
    Malfunction
    Date Received
    September 10, 2011
    Date of Event
    August 11, 2011
    Report Date
    August 11, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    GKZ
    PMA / PMN Number
    K081930
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO SERVICE WAS REQUESTED FOR THIS EVENT. THE CUSTOMER STATED THAT THE SPILL OCCURRED BECAUSE THE DRAIN WHERE THE INSTRUMENTS WASTE TUBES ARE CONNECTED BECAME CLOGGED AND CAUSED THE WASTE TO BACKWASH AND SPILL. THE CUSTOMER RESOLVED THE ISSUE BY UNCLOGGING THE DRAIN. ROOT CAUSE FOR THE LEAK WAS THAT THE DRAIN WHERE THE WASTE TUBING IS CONNECTED WAS CLOGGED. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BECKMAN COULTER INC (BEC) TO REPORT FINDING WASTE RESIDUE ON THE FLOOR, WALL, & DRAIN CAP WHERE THE WASTE LINES FOR TWO DXH800 INSTRUMENTS ARE CONNECTED TO THE DRAIN. THE USER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF GOWN, GLOVES AND EYE GOGGLES AT THE TIME OF THE INCIDENT. THE MATERIAL SAFETY DATA SHEET (MSDS) WAS NOT REVIEWED; HOWEVER, IT IS READILY AVAILABLE. NO INJURIES OCCURRED AND MEDICAL ATTENTION WAS NOT SOUGHT. NO REPORTS OF EXPOSURE TO MUCOUS MEMBRANES OR OPEN WOUNDS. THE LAB'S EXPOSURE CONTROL OR RISK MANAGEMENT PLANS ARE IN PLACE. THE OTHER INSTRUMENT EVENT HAS BEEN CAPTURED UNDER MDR 1061932-2011-01434.

    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. DXH800 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1