BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 500 HEMATOLOGY ANALYZER

    MDR report key: 3093275 · Received May 6, 2013

    Report

    Report Number
    1061932-2013-00747
    Event Type
    Malfunction
    Date Received
    May 6, 2013
    Date of Event
    April 10, 2013
    Report Date
    April 10, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K032000
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) ASSISTED THE CUSTOMER TO RESOLVE THE LEAK BY PHONE. THE FSE STATED THAT THE CUSTOMER OBSERVED AN ISOTON RESIDUE UNDER THE BLOOD SAMPLING VALVE (BSV) MODULE. THE FSE INSTRUCTED THE OPERATOR TO CLEAN THE PROBE AND THE BSV CORRECTLY AS WELL AS TIGHTEN THE BSV KNOB, RESOLVING THE LEAK. THE CUSTOMER VERIFIED THAT THE UNIT WAS OPERATIONAL AND QUALITY QONTROL (QC) RESULTS WERE WITHIN RANGE. THERE WERE NO FURTHER LEAKS OR ERROR MESSAGES REPORTED BY THE OPERATOR WHEN THE FSE CONTACTED THE CUSTOMER THE FOLLOWING DAY. FAILURE MODE WAS RELATED TO THE BSV. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BECKMAN COULTER THAT THERE WAS A FLUID LEAK OF APPROXIMATELY 1ML FROM THE BACKWASH CUP OF THE COULTER LH 500 HEMATOLOGY ANALYZER. THE LEAK WAS NOT CONTAINED WITHIN THE INSTRUMENT. THE ANALYZER GENERATED PC1 ERROR MESSAGE AT THE TIME OF THE LEAK. THE MATERIAL SAFETY DATA SHEET (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), CONSISTING OF A LABORATORY COAT, GLOVES AND PROTECTIVE EYEWEAR AT THE TIME OF THE INCIDENT. THERE WAS NO BIOHAZARD EXPOSURE TO OPEN WOUNDS OR MUCOUS MEMBRANES. THE OPERATOR DID NOT SEEK MEDICAL ATTENTION. NO ERRONEOUS RESULTS WERE ASSOCIATED 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
    196023 COULTER® LH 500 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER LH 500 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1