BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DXH HEMATOLOGY SYSTEM

    MDR report key: 2355274 · Received December 1, 2011

    Report

    Report Number
    1061932-2011-02459
    Event Type
    Malfunction
    Date Received
    December 1, 2011
    Date of Event
    November 8, 2011
    Report Date
    November 8, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K081930
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A SMALL AMOUNT OF DRIED BLOOD-TINGED MATERIAL WAS OBSERVED ON THE CONTROL PACKAGING OF THE BECKMAN COULTER DXH800 BODY FLUID (BF) CONTROL WHEN IT WAS TAKEN OUT OF THE REFRIGERATOR FOR INSTRUMENT TESTING. UPON FURTHER INSPECTION, A HOLE WAS NOTICED ON THE LEVEL 3 CONTROL VIAL STOPPER WHERE IT HAD BEEN PIERCED AFTER ONLY SEVEN (7) ASPIRATIONS. THE TUBE LEAKED WHEN IT WAS LAID DOWN. THE OPERATOR WAS WEARING A LAB COAT, GLOVES AND EYE PROTECTION AT THE TIME OF THE EVENT. THERE WAS NO CONTACT TO MUCOUS MEMBRANES OR OPEN WOUNDS. THERE WAS NO DEATH, INJURY, OR AFFECT TO PATIENT TREATMENT. NO ONE SOUGHT MEDICAL ATTENTION. THERE WAS NO REVIEW OF THE MSDS. THERE IS AN EXPOSURE CONTROL PLAN AT THE FACILITY. THE LEVEL 3 VIALS FOR THE OTHER TWO DXH800 ANALYZERS ALSO HAD NOTICEABLE PIERCE MARKS IN THEM. A SET OF CONTROLS IS KEPT FOR EACH INSTRUMENT. THE OTHER BF CONTROL VIALS, LEVELS 1 AND 2, DID NOT SHOW ANY SIMILAR PIERCE MARKS. THERE WAS NO SERVICE DISPATCHED FOR THIS EVENT. REPLACEMENT WAS NOT REQUESTED. ROOT CAUSE FOR THE LEAK IS UNKNOWN. PER LABELING: THIS SPECIMEN/REAGENT SHOULD BE HANDLED AT BIOSAFETY LEVEL 2, AS RECOMMENDED FOR ANY POTENTIALLY INFECTIOUS HUMAN SERUM OR BLOOD SPECIMEN IN THE CENTERS FOR DISEASE CONTROL/NATIONAL INSTITUTES OF HEALTH MANUAL "BIOSAFETY IN MICROBIOLOGICAL AND BIOMEDICAL LABORATORIES," 1988. BECKMAN COULTER, INC. URGES ITS CUSTOMERS TO COMPLY WITH ALL NATIONAL HEALTH AND SAFETY STANDARDS SUCH AS THE USE OF BARRIER PROTECTION. THIS MAY INCLUDE, BUT IS NOT LIMITED TO, PROTECTIVE EYEWEAR, GLOVES, AND SUITABLE LABORATORY ATTIRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DXH HEMATOLOGY SYSTEM COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER, INC. DXH 800

    Patients

    Seq Age Sex Outcome Treatment
    1