BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LH750

    MDR report key: 2348493 · Received November 25, 2011

    Report

    Report Number
    1061932-2011-02428
    Event Type
    Malfunction
    Date Received
    November 25, 2011
    Date of Event
    October 29, 2011
    Report Date
    October 29, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K011342
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE PRESENCE OF A CLEAR LIQUID DRIPPING ON THE LEFT SIDE OF THE LH750 ANALYTICAL STATION. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF A LAB COAT, EYE PROTECTION, AND GLOVES. THE CUSTOMER DID NOT COME IN CONTACT WITH THE FLUID. MEDICAL ATTENTION WAS NOT SOUGHT. THERE WAS NO REPORT OF EXPOSURE TO MUCOUS MEMBRANES OR OPEN WOUNDS. NO ONE WAS SPLASHED OR SPRAYED. THE MATERIAL SAFETY DATA SHEET (MSDS) WAS NOT REVIEWED. THERE WAS NO DEATH, INJURY OR CHANGE TO PATIENT TREATMENT ATTRIBUTED OR ASSOCIATED TO THIS COMPLAINT, NOR WAS THERE IMPACT TO PATIENT RESULTS AS A RESULT OF THIS EVENT. THE CUSTOMER CONTACT GUIDED THE CUSTOMER THROUGH THE TROUBLESHOOTING PROCESS VIA TELEPHONE. THE CUSTOMER CHECKED RETIC CLEARING SOLUTION (GHOST PUMP PM6) AND FOUND IT DRIPPING AT THE TIP OF THE Y FITTING (FY85-A). CUSTOMER CONTACT HAD THE CUSTOMER POWER OFF THE INSTRUMENT, REMOVE THE TUBING, TRIM THE TIP OF THE TUBING AND RECONNECT IT. CUSTOMER CALLED BACK LATER IN THE DAY TO REPORT THAT THE TUBING CONTINUES TO DISCONNECT. A FIELD SERVICE ENGINEER (FSE) SENT TO REPLACE THE TUBING. THERE WAS NO FURTHER EVIDENCE OF LEAKING. ROOT CAUSE FOR THE LEAK IS THE TUBING FROM THE RETIC CLEARING SOLUTION (PM6) DISCONNECTING. PER LABELING, 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 IT IS NOT LIMITED TO, PROTECTIVE EYEWEAR, GLOVES, AND SUITABLE LABORATORY ATTIRE WHEN OPERATING OR MAINTAINING THIS OR ANY OTHER AUTOMATED LABORATORY ANALYZER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LH750 COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER, INC. LH750

    Patients

    Seq Age Sex Outcome Treatment
    1