BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 750 HEMATOLOGY ANALYXZER

    MDR report key: 3031833 · Received April 2, 2013

    Report

    Report Number
    1061932-2013-00474
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Date of Event
    March 7, 2013
    Report Date
    March 7, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K011342
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE. THE FSE FOUND A PINHOLE LEAK IN PINCH VALVE (VL) 4B TUBING. THE FSE REPLACED THE TUBING WHICH RESOLVED THE LEAK. THE FSE ALSO FOUND A PRESSURE LEAK AT TUBING ATTACHED TO THE ROCKER BED AIR CYLINDER. THE FSE TRIMMED THE TUBING CORRECTING THE AIR LEAK. A PRESSURE LEAK AT THE ROCKER BED MAY CAUSE INSTRUMENT MALFUNCTION IF SOLENOIDS DO NOT HAVE ENOUGH PRESSURE TO OPEN AND CLOSE. HOWEVER, THIS MALFUNCTION WILL NOT AFFECT PATIENT RESULTS AS THE INSTRUMENT WILL BECOME INOPERABLE NOT ALLOWING THE INSTRUMENT TO DETECT THE NEXT TUBE FOR SAMPLE ASPIRATION. SERVICE ACTIVITY WAS PERFORMED AND WAS VERIFIED TO MEET THE SPECIFIED REQUIREMENTS PER ESTABLISHED PROCEDURE. FAILURE MODE IS RELATED TO A PINHOLE LEAK IN VL4B TUBING. THE PRESSURE LEAK WAS DUE TO THE TUBING ATTACHED TO THE ROCKER BED AIR CYLINDER. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BECKMAN COULTER (BEC) A LEAK OF 25 ML IN VOLUME ON THE RIGHT SIDE OF THE COULTER LH 750 HEMATOLOGY ANALYZER. THE LEAK WAS NOT CONTAINED WITHIN THE INSTRUMENT. THE MSDS WAS NOT REVIEWED BY THE CUSTOMER. THERE IS AN EXPOSURE CONTROL/RISK MANAGEMENT PLAN IN PLACE AT THE FACILITY. THE OPERATOR WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE), INCLUDING A LABORATORY COAT AND GLOVES AT THE TIME OF THE EVENT. THERE WAS NO BIOHAZARD EXPOSURE TO OPEN WOUNDS OR MUCOUS MEMBRANES. THE OPERATOR DID NOT SEEK MEDICAL ATTENTION. NO ERRONEOUS RESULTS WERE GENERATED IN CONNECTION WITH THIS EVENT. NO DEATH OR INJURY IS ATTRIBUTED TO THIS EVENT AND THERE WAS NO CHANGE TO PATIENT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134650 COULTER® LH 750 HEMATOLOGY ANALYXZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER LH 750 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1