BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 500 HEMATOLOGY ANALYZER

    MDR report key: 2960228 · Received February 14, 2013

    Report

    Report Number
    1061932-2013-00196
    Event Type
    Malfunction
    Date Received
    February 14, 2013
    Date of Event
    January 20, 2013
    Report Date
    January 20, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K042724
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS NOT DISPATCHED AS THE CUSTOMER RESOLVED THE ISSUE THROUGH TROUBLESHOOTING VIA THE TELEPHONE. IT WAS DETERMINED FLUID LEAKED FROM THE NEEDLE DUE TO DETERIORATION OF THE PLASTIC CASING AROUND THE NEEDLE AND WAS CAUSING PARTIAL ASPIRATION AND LEAKAGE NEAR THE NEEDLE ASSEMBLY. THE CUSTOMER REPLACED THE NEEDLE ASSEMBLY AND RESOLVED THE ISSUE. THE INSTRUMENT WAS RETURNED TO NORMAL OPERATION. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED APPROXIMATELY ONE FOURTH CUP OF DILUTED BLOOD FLUID LEAKED ONTO THE COUNTER AND FLOOR DURING ONE SAMPLE ANALYSIS INVOLVING THE COULTER LH 500 HEMATOLOGY ANALYZER. THE CUSTOMER HAD ON 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. PATIENT RESULTS WERE NOT GENERATED. THERE WAS NO PATIENT IMPACT. THE LABORATORY HAS AN EXPOSURE CONTROL PLAN IN PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64171 COULTER® LH 500 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1