BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BECKMAN COULTER ¿ COULTER ® LH 750 HEMATOLOGY ANALYZER

    MDR report key: 2873197 · Received December 13, 2012

    Report

    Report Number
    1061932-2012-02816
    Event Type
    Malfunction
    Date Received
    December 13, 2012
    Date of Event
    November 14, 2012
    Report Date
    November 14, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K011342
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) VISITED THE SITE AND EVALUATED THE SYSTEM. THE FSE FOUND THE CLEAR FLUID LEAK WAS CAUSED BY THE LOWER SHEATH RESTRICTOR THAT HAD COME OFF THE Y FITTING ON THE SHEATH TANK SIDE. THE FSE REPLACED THE LOWER SHEATH RESTRICTOR. THE FSE RAN A CASSETTE OF SAMPLES AND NO OTHER FLUID LEAKS OF ANY TYPE WERE FOUND AND THE REPORTED LEAK WAS FIXED. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BECKMAN COULTER INC. (BEC) THAT A CLEAR FLUID WAS LEAKING FROM THE RIGHT SIDE OF THE COULTER LH 750 HEMATOLOGY ANALYZER. THE VOLUME OF FLUID WAS 10 MLS AND THE LEAK WAS NOT CONTAINED WITHIN THE INSTRUMENT. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT. NO INJURIES WERE SUSTAINED BY ANY LAB PERSONNEL. THERE ARE NO REPORTS OF ERRONEOUS RESULTS OR ADVERSE PATIENT EVENTS. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE SITE TO EVALUATE THE SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BECKMAN COULTER ¿ COULTER ® LH 750 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER, INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1