BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® ACT 8/10 ANALYZER

    MDR report key: 3180788 · Received June 20, 2013

    Report

    Report Number
    1061932-2013-01128
    Event Type
    Malfunction
    Date Received
    June 20, 2013
    Date of Event
    May 27, 2013
    Report Date
    May 27, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K973634
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE. THE FSE INDICATED THAT THE INSTRUMENT WAS GETTING VACUUM ERRORS. UPON FURTHER INSPECTION, THE FSE DISCOVERED THAT THE VACUUM CHAMBER WAS FULL AND NOT DRAINING. THE FSE FOUND THE SOLENOID LV15 WAS NOT ACTIVATING, AND REPLACED THE LV15. AFTER REPLACING THE SOLENOID, VACUUM RETURNED AND THE VACUUM CHAMBER DRAINED AS NORMAL. SYSTEM PERFORMANCE WAS VERIFIED, AND THERE WERE NO FURTHER ERROR MESSAGES REPORTED. FAILURE MODE WAS RELATED TO THE SOLENOID LV15. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BECKMAN COULTER (BEC) THAT THERE WAS A RED FLUID LEAK OF APPROXIMATELY 5 ML FROM THE SMPLING PROBE OF THE COULTER ACT 8/10 ANALYZER. THE LEAK WAS NOT CONTAINED WITHIN THE INSTRUMENT. THE MATERIAL SAFETY DATA SHEET (MSDS) WAS NOT REVIEWED BY THE CUSTOMER. THERE IS AN EXPOSURE CONTROL/RISK MANAGEMENT PLAN IN PLACE AT THE FACILITY. THE OPERATOR WAS WEARING A LABORATORY COAT AND GLOVES AT THE TIME OF THE INCIDENT. THERE WAS NO BIOHAZARD EXPOSURE TO OPEN WOUNDS OR MUCOUS MEMBRANES. THE OPERATOR DID NOT SEEK MEDICAL ATTENTION. NO ERRONEOUS RESULTS WERE ASSOCIATED WITH THE REPORTED LEAK. NO DEATH OR INJURY IS ATTRIBUTED TO THIS EVENT AND THERE WAS NO CHANGE TO PATIENT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281495 COULTER® ACT 8/10 ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA

    Patients

    Seq Age Sex Outcome Treatment
    1