BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 750 HEMATOLOGY ANALYZER

    MDR report key: 2981759 · Received February 27, 2013

    Report

    Report Number
    1061932-2013-00317
    Event Type
    Malfunction
    Date Received
    February 27, 2013
    Date of Event
    February 1, 2013
    Report Date
    February 1, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K011342
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) DISCOVERED A CUT IN THE SHEATH LINE TUBING AT THE UPPER SHEATH RESTRICTOR. THE FSE REPLACED THE TUBING AND RESOLVED THE FLUID LEAK ISSUE. THE INSTRUMENT CONFORMED TO THE MANUFACTURER'S PUBLISHED SPECIFICATIONS AND WAS RETURNED TO NORMAL OPERATION. (B)(4).

    Description of Event or Problem · 1

    THE AFFILIATE REPORTED THE CUSTOMER ALLEGED APPROXIMATELY THREE MILLILITERS OF CLEAR FLUID LEAKED OUTSIDE THE INSTRUMENT, FROM THE PINCH VALVE ON-SHEATH FLOW RESISTOR INVOLVING THE COULTER LH 750 HEMATOLOGY ANALYZER. THE OPERATOR WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF GLOVES AND A LABORATORY COAT AND DID NOT HAVE DIRECT CONTACT WITH THE FLUID. THERE WAS NO OPERATOR INJURY OR ADVERSE EFFECT ASSOCIATED WITH THIS EVENT. THE CUSTOMER HAS AN EXPOSURE CONTROL PLAN AT THE FACILITY. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84283 COULTER® LH 750 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1