BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER HMX ANALYZER WITH AUTOLOADER

    MDR report key: 2430740 · Received January 30, 2012

    Report

    Report Number
    1061932-2012-00234
    Event Type
    Malfunction
    Date Received
    January 30, 2012
    Date of Event
    December 30, 2011
    Report Date
    December 30, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K010765
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE ROOT CAUSE FOR THE LEAK WAS THE MISALIGNMENT OF THE PROBE RINSE BLOCK, WHICH WAS RESOLVED AFTER THE FSE PERFORMED THE SERVICES DESCRIBED. (NOTE: THE BECKMAN COULTER, INC. IDENTIFIER FOR THIS REPORT IS (B)(4).)

    Description of Event or Problem · 1

    CUSTOMER CALLED TO REPORT THAT THE PROBE WASH OF THE COULTER HMX ANALYZER WITH AUTOLOADER WAS LEAKING DILUENT/BLOOD WHILE TRYING TO CLEAN THE PROBE AFTER ASPIRATION. CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF A LABORATORY COAT, EYE PROTECTION, AND GLOVES. CUSTOMER DID NOT COME IN CONTACT WITH THE FLUID, AND MEDICAL ATTENTION WAS NOT SOUGHT. THERE WAS NO REPORT OF EXPOSURE TO MUCOUS MEMBRANES OR OPEN WOUNDS, AND NO ONE WAS SPLASHED OR SPRAYED. THERE WAS NO DEATH, INJURY OR CHANGE TO PATIENT TREATMENT ATTRIBUTED TO OR ASSOCIATED WITH THIS COMPLAINT, NOR WAS THERE IMPACT TO PATIENT RESULTS AS A RESULT OF THIS EVENT. THE FIELD SERVICE ENGINEER (FSE) OBSERVED THAT THE PROBE RINSE BLOCK WAS MISALIGNED. THE FSE ADJUSTED THE PROBE RINSE BLOCK UPWARD SO THAT THE LOWER FITTING LINED UP WITH THE OUTPUT ON THE PROBE. THERE WAS NO FURTHER EVIDENCE OF LEAKING, AND THE FSE VERIFIED INSTRUMENT PERFORMANCE TO ENSURE THAT THE SERVICES PERFORMED EFFECTIVELY RESOLVED THE INSTRUMENT ISSUE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1