BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAVIOS? FLOW CYTOMETER SYSTEM

    MDR report key: 3580061 · Received January 16, 2014

    Report

    Report Number
    1061932-2014-00110
    Event Type
    Malfunction
    Date Received
    January 16, 2014
    Date of Event
    December 16, 2013
    Report Date
    December 17, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    OYE
    PMA / PMN Number
    K130373
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER'S SITE ON (B)(4) 2013. THE FSE EVALUATED THE GALLIOS FLOW CYTOMETER AND CONFIRMED THAT THE VORTEXER HAD FAILED. THE FSE RETURNED TO THE CUSTOMER'S SITE ON (B)(4) 2013 TO REPLACE THE MULTI CAROUSEL LOADER (MCL) LIFTER MOTOR ASSEMBLY ON THE GALLIOS FLOW CYTOMETER, MAKING THE UNIT OPERATIONAL. FAILURE MODE OF THE EVENT IS ATTRIBUTED TO THE VORTEXER MIXER MOTOR. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE VORTEXER TO THE MULTI CAROUSEL LOADER (MCL) SIDE OF THE GALLIOS FLOW CYTOMETER IS NOT WORKING. THE GALLIOS FLOW CYTOMETER IS A NOT AN IN-VITRO DIAGNOSTIC (IVD) INSTRUMENT AND IS FOR RESEARCH USE ONLY. THIS REPORT REFERENCES THE NAVIOS FLOW CYTOMETER SYSTEM WHICH IS AN IVD INSTRUMENT AND IS SIMILAR IN DESIGN AND FUNCTION TO THE GALLIOS FLOW CYTOMETER. THE VORTEXER IS A COMMON PART ON BOTH INSTRUMENTS AND IS PART OF THE MCL LIFTER MOTOR ASSEMBLY. ITS PURPOSE IS TO LIFT THE SAMPLE TUBE FROM THE CAROUSEL AND VORTEX (MIX) THE SAMPLE JUST PRIOR TO ASPIRATION BY THE INSTRUMENT. NO ERRONEOUS RESULTS WERE GENERATED AND THERE WAS NO CHANGE OR AFFECT TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT. GALLIOS FLOW CYTOMETER PART NUMBER A94304 WITH SERIAL NUMBER (B)(4) WAS INVOLVED IN THIS EVENT. THIS GALLIOS' INSTRUMENT DATE OF MANUFACTURE IS MARCH 13, 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    42300 NAVIOS? FLOW CYTOMETER SYSTEM FLOW CYTOMETRIC REAGENTS AND ACCESSORIES. OYE BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1