BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® HMX WITH AUTOLOADER

    MDR report key: 2763424 · Received September 27, 2012

    Report

    Report Number
    1061932-2012-02440
    Event Type
    Malfunction
    Date Received
    September 27, 2012
    Date of Event
    September 4, 2012
    Report Date
    September 4, 2012
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    GKZ
    PMA / PMN Number
    K010765
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WENT ON-SITE THE DAY OF THE EVENT AND FOUND THAT THE TUBING AT PORT 9 OF THE BLOOD SAMPLING VALVE (BSV) WAS STRETCHED AND WOULD NOT CREATE A TIGHT SEAL AROUND THE FITTING. FSE REPLACED THE TUBING AND THE LEAK WAS REPAIRED. REPAIR WAS VERIFIED PER ESTABLISHED PROCEDURES. THE CAUSE OF THE LEAK WAS THAT THE TUBING AT PORT 9 OF THE BSV WAS LOOSE AT THE FITTING. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) REPORTING A LEAK OF APPROXIMATELY 3ML AT THE MANUAL MODE PROBE WASH OF THEIR COULTER HMX INSTRUMENT. THE LEAK WAS NOT CONTAINED WITHIN THE INSTRUMENT, THE OPERATOR WAS WEARING GLOVES WHEN THE LEAK WAS DISCOVERED. NO INJURY OR EXPOSURE WAS REPORTED AND NO PATIENT SAMPLES OR RESULTS WERE AFFECTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1