BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 750 HEMATOLOGY ANALYZER

    MDR report key: 3062310 · Received April 16, 2013

    Report

    Report Number
    1061932-2013-00652
    Event Type
    Malfunction
    Date Received
    April 16, 2013
    Date of Event
    March 19, 2013
    Report Date
    March 19, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K011342
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) DISCOVERED THE YELLOW STRIPE TUBING, WHICH CARRIES THE WASTE FROM THE BACKWASH CYCLE OF THE PROBE TO THE WASTE CHAMBER, HAD COME OFF AT THE LOWER END OF THE PROBE WIPE BLOCK. THE FSE REPLACED THE TUBING AND RESOLVED THE FLUID LEAK. SERVICE ACTIVITY PERFORMED WAS VERIFIED TO MEET THE SPECIFIED REQUIREMENTS PER ESTABLISHED PROCEDURES. THE INSTRUMENT CONFORMED TO THE MANUFACTURER'S PUBLISHED SPECIFICATIONS AND WAS RETURNED TO NORMAL OPERATION. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED CLEAR FLUID, WITH A TRACE OF BLOOD, LEAKED UNDER THE MANUAL SAMPLING PROBE, UNDER THE WASH BLOCK AREA, AND ONTO THE COUNTER DURING QUALITY CONTROL (QC) INVOLVING THE COULTER LH 750 HEMATOLOGY ANALYZER. THE CUSTOMER STATED THE LEAK OCCURRED ONLY IN MANUAL MODE. THE OPERATOR WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF GLOVES AND A LABORATORY COAT AND CLEANED UP THE FLUID. THE OPERATOR DID NOT HAVE DIRECT CONTACT WITH THE FLUID. THERE WAS NO OPERATOR INJURY OR ADVERSE EFFECT ASSOCIATED WITH THIS EVENT. PATIENT RESULTS WERE NOT IMPACTED. THE LABORATORY HAS AN EXPOSURE CONTROL PLAN IN PLACE. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162496 COULTER® LH 750 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1