BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER HMX HEMATOLOGY ANALYZER WITH AUTOLOADER

    MDR report key: 4243652 · Received November 11, 2014

    Report

    Report Number
    1061932-2014-02809
    Event Type
    Malfunction
    Date Received
    November 11, 2014
    Date of Event
    October 19, 2014
    Report Date
    October 19, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K010765
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2014, A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) EVALUATED THE ANALYZER AND CONFIRMED THE LEAK FROM CUT TUBING THROUGH PINCH VALVE, PV 43. THE FSE REPLACED THE TUBING RESOLVING THE LEAK. THE FSE FOUND THE LEAK HAD AFFECTED THE FOLLOWING COMPONENTS, WHICH WERE REPLACED: THE MIXING MOTOR, SOLENOIDS ON THE 10 SOLENOID MANIFOLD, AND THE HARNESS. THE FSE POWERED THE ANALYZER ON, AND IDENTIFIED A BURNING ODOR FROM THE CARD CAGE OF THE ANALYZER. THE LEAK HAD AFFECTED THE ICU8 CHIP ON THE IF BOARD. THE ICU8 CHIP WAS BURNED, CRACKED, AND STARTED MELTING. THE FSE REPLACED THE DILUTER IF AND I/O BOARD RESOLVING THE ISSUE. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A LEAK IN THE COULTER HMX HEMATOLOGY ANALYZER WITH AUTOLOADER. THE LEAK WAS DESCRIBED AS 200 ML OF BLUE FLUID THAT LEAKED FROM CUT TUBING AT PINCH VALVE PV 43. THE LEAK WAS NOT CONTAINED WITHIN THE ANALYZER, AND LEAKED ONTO THE COUNTERTOP AND FLOOR. THE LEAK WAS IDENTIFIED AFTER PERFORMING AN INSTRUMENT SHUTDOWN AND STARTUP. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE CUSTOMER'S FACILITY TO EVALUATE THE ANALYZER. THE FSE IDENTIFIED SEVERAL COMPONENTS OF THE ANALYZER THAT WERE DAMAGED DUE TO THE LEAK. A BURNING SMELL WAS ALSO IDENTIFIED, HOWEVER, THERE WERE NO ARCS, SPARKS, SMOKE, OR FLAMES REPORTED. THE FIRE DEPARTMENT WAS NOT CALLED AND A FIRE EXTINGUISHER WAS NOT USED. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT OF GLOVES, GLASSES, AND LAB COAT AT THE TIME OF THE OCCURRENCE. THERE WAS NO BIOHAZARD EXPOSURE TO OPEN WOUNDS OR MUCOUS MEMBRANES. THERE WERE NO ERRONEOUS TEST RESULTS ASSOCIATED WITH THIS EVENT. THERE WAS NO DEATH, INJURY OR AFFECT TO THE USER OR PATIENT TREATMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    727023 COULTER HMX HEMATOLOGY ANALYZER WITH AUTOLOADER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1