BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER EPICS XL FLOW CYTOMETER

    MDR report key: 4223178 · Received November 4, 2014

    Report

    Report Number
    1061932-2014-02742
    Event Type
    Malfunction
    Date Received
    November 4, 2014
    Date of Event
    October 16, 2014
    Report Date
    October 16, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K990172
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2014, THE FIELD SERVICE ENGINEER (FSE) EVALUATED THE INSTRUMENT AND STATED NO FLUID LEAKED; THE PNEUMATIC DRAWER WAS DRY AND CLEAN. THE COMPRESSOR WAS CHECKED FOR LEAKS AND NONE WAS FOUND. THE SOURCE OF THE LEAK WAS UNKNOWN. THE HISSING SOUND WAS COMING FROM THE SAMPLE HEAD THAT WAS MALFUNCTIONING. THE FSE REPLACED THE SAMPLE HEAD, RAN CONTROLS AND THE INSTRUMENT WORKED EXPECTED.

    Description of Event or Problem · 1

    A LEAK WAS REPORTED WHEN USING THE EPICS XL 4C FLOW CYTOMETER. THE OPERATOR WAS RUNNING THE FLOW CHECK ALIGNMENT FLUOROSPHERES, WHEN AN UNUSUAL (HISSING) SOUND WAS IDENTIFIED. THE OPERATOR OBSERVED 5 ML OF CLENZ FLUID UNDERNEATH THE POWER SUPPLY. THE OPERATOR CLEANED THE AREA. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS SENT TO EVALUATE THE INSTRUMENT. THE FSE COULD NOT IDENTIFY A LEAK. THE FSE DID IDENTIFY THE HISSING SOUND WAS COMING FROM THE SAMPLE HEAD THAT WAS MALFUNCTIONING. THE OPERATOR WAS WEARING LAB COAT, GLASSES, AND GLOVES AT THE TIME OF THE INCIDENT. THERE WAS NO REPORT OF BIOHAZARD EXPOSURE TO MUCOUS MEMBRANES OR OPEN WOUNDS. THERE WERE NO ERRONEOUS TEST RESULTS ASSOCIATED WITH THIS EVENT. THERE WAS NO DEATH, INJURY OR AFFECT TO USER OR PATIENT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    705995 COULTER EPICS XL FLOW CYTOMETER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1