BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER HMX ANALYZER WITH AUTOLOADER

    MDR report key: 2446511 · Received February 10, 2012

    Report

    Report Number
    1061932-2012-00375
    Event Type
    Malfunction
    Date Received
    February 10, 2012
    Date of Event
    January 16, 2012
    Report Date
    January 16, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K010765
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) THAT THE COULTER HMX ANALYZER WITH AUTOLOADER (HMX AUTOLOADER) WAS LEAKING FROM THE NEEDLE BELLOWS. CUSTOMER REPORTED THAT THE FLUID APPEARED TO BE CLENZ, DILUENT, AND SOME SAMPLE. CUSTOMER REPORTED THAT A SCREW THAT HELD THE BOTTOM OF THE NEEDLE BELLOWS WAS LOOSE. THERE WAS NO REPORT OF PATIENT RESULTS AFFECTED. THERE WAS NO REPORT OF ANY ADVERSE EVENT OR INJURY REQUIRING MEDICAL INTERVENTION OR PATIENT TREATMENT. BEC FIELD SERVICE ENGINEER (FSE) FOUND THE HMX AUTOLOADER WAS LEAKING FROM THE BELLOWS AND OBSERVED THE SCREW HOLDING THE BOTTOM OF THE BELLOWS WAS LOOSE, CAUSING THE BELLOWS NOT TO LOWER ALL THE WAY. THE FSE TIGHTENED THE SCREW AND CLEANED THE INSTRUMENT AND THE COUNTER. THE FSE VERIFIED THE REPAIRS WERE PERFORMED PER ESTABLISHED PROCEDURES. THE FSE VERIFIED THE RESULTS MET PUBLISHED PERFORMANCE SPECIFICATIONS.

    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 AUTOLOADER

    Patients

    Seq Age Sex Outcome Treatment
    1