BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® HMX HEMATOLOGY ANALYZER WITH AUTOLOADER

    MDR report key: 3785238 · Received May 1, 2014

    Report

    Report Number
    1061932-2014-00972
    Event Type
    Malfunction
    Date Received
    May 1, 2014
    Date of Event
    April 10, 2014
    Report Date
    April 10, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K010765
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, 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 INSTRUMENT AND FOUND THAT THE BLOOD SAMPLING VALVE (BSV) WAS CLOGGED. HE FLUSHED THE BSV WITH BLEACH FROM SAMPLE LINE TO FLOW CELL TO RESOLVE THE ISSUES. THE FSE THEN PERFORMED VERIFICATION OF INSTRUMENT TO MEET THE SPECIFIED REQUIREMENTS PER ESTABLISHED PROCEDURES. (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 LESS THAN 1 CC OF DILUTED BLOOD FROM THE BLOOD SAMPLING VALVE (BSV) PROBE AFTER BACKWASHING. THE WHITE BLOOD CELL (WBC) BACKGROUND WAS INCOMPLETE (+++) UPON INSTRUMENT STARTUP. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT OF GLOVES AND A LAB COAT WHEN THE LEAK WAS DISCOVERED. 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 ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261560 COULTER® HMX HEMATOLOGY ANALYZER WITH AUTOLOADER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1