BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH750 SLIDEMAKER

    MDR report key: 2461704 · Received February 20, 2012

    Report

    Report Number
    1061932-2012-00411
    Event Type
    Malfunction
    Date Received
    February 20, 2012
    Date of Event
    January 24, 2012
    Report Date
    January 24, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKJ
    PMA / PMN Number
    CL1 EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FIELD SERVICE ENGINEER (FSE) FOUND A LEAK IN THE BLACK STRIPE TUBING IN THE DISPENSE MODULE. THE FSE REPLACED THE AFFECTED TUBING AND SEVERAL TUBING SURROUNDING THE AREA. THE FSE CLEANED THE PROBE, RINSE BLOCK, AND THE SPILL. THERE WAS NO FURTHER EVIDENCE OF LEAKING. REPAIRS WERE VERIFIED AS PER ESTABLISHED PROCEDURES. THE RESULTS MET PUBLISHED PERFORMANCE SPECIFICATIONS. THE DISPENSE MODULE MAY HAVE THE PRESENCE OF BLOOD AND DILUENT WHILE IN OPERATION AND CLEANER WHILE IN SHUTDOWN. THE CAUSE OF THE LEAK WAS A BLACK STRIPE TUBING IN THE DISPENSE MODULE. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BECKMAN COULTER INC (BEC) THAT THERE WAS BLOOD LEAK UNDERNEATH THE COULTER LH750 SLIDEMAKER. THE OPERATOR WAS WEARING A LAB COAT AND GLOVES AT THE TIME OF THE EVENT. THERE WAS NO EXPOSURE TO MUCOUS MEMBRANES OR OPEN WOUNDS. NO ONE SOUGHT MEDICAL ATTENTION. THE MATERIAL SAFETY DATA SHEET (MSDS) WAS REVIEWED, AND THERE IS AN EXPOSURE CONTROL PLAN AT THE FACILITY. PATIENT RESULTS WERE NOT AFFECTED, AND THERE WAS NO DEATH, INJURY OR CHANGE TO PATIENT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER® LH750 SLIDEMAKER SPINNER, SLIDE, AUTOMATED GKJ BECKMAN COULTER, INC. LH750 NA

    Patients

    Seq Age Sex Outcome Treatment
    1