BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXH 800 COULTER® CELLULAR ANALYSIS SYSTEM

    MDR report key: 2283514 · Received October 7, 2011

    Report

    Report Number
    1061932-2011-01676
    Event Type
    Malfunction
    Date Received
    October 7, 2011
    Date of Event
    September 11, 2011
    Report Date
    September 12, 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
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS DISPATCHED AND THE FIELD SERVICE ENGINEER (FSE) FOUND THAT THE NRBC CHAMBER WAS SPILLING. THE NRBC DRAIN WAS CLOGGED WITH WHAT APPEARED TO BE A BLOOD CLOT AND FIBROUS MATERIAL. THE NRBC CHAMBER OF THE INSTRUMENT CAN CONTAIN BLOOD, DILUENT, DIFF PACK (ERYTHROLYSES AND STABILISE) OR CLEANER. THE FSE REPLACED THE CHAMBER. THE REPAIRS WERE VERIFIED PER ESTABLISHED PROCEDURES. ROOT CAUSE FOR THE LEAK IS ATTRIBUTED TO A CLOG IN THE DRAIN OF THE NRBC MIXING CHAMBER. BEC INTERNAL IDENTIFIER FOR THIS COMPLAINT IS (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) A BLUISH LEAK INSIDE UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM. THE CUSTOMER WAS WEARING PPE INCLUDING GLOVES, LAB COAT, AND EYE PROTECTION AT THE TIME OF THE EVENT. THERE WAS NO REPORT OF EXPOSURE TO MUCOUS MEMBRANE OR OPEN WOUNDS. NO INJURIES OCCURRED AND NO ONE SOUGHT MEDICAL ATTENTION. MSDS WAS NOT REVIEWED, BUT IS READILY AVAILABLE. THE FACILITY HAS EXPOSURE CONTROL PLAN. THERE WAS NO DEATH, INJURY OR CHANGE TO PATIENT TREATMENT AS A RESULT OF THIS INCIDENT.

    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 NA

    Patients

    Seq Age Sex Outcome Treatment
    1