BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 750 HEMATOLOGY ANALYZER

    MDR report key: 3183385 · Received June 21, 2013

    Report

    Report Number
    1061932-2013-01234
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    May 23, 2013
    Report Date
    May 23, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K011342
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) OBSERVED THE ERYTHROLYSES PUMP LEAKED DUE TO A BROKEN SPRING INSIDE THE PUMP. THE FSE REPLACED THE AFFECTED PUMP. THE FSE OBSERVED THE ROCKER BED MALFUNCTION DUE TO THE SENSOR DISTRIBUTION BOARD. THE FSE INSTALLED A NEW SENSOR DISTRIBUTION BOARD AND RESOLVED THE ISSUE. WHILE ONSITE, THE FSE INCIDENTALLY REPLACED THE WORKSTATION COMPUTER AND PERFORMED LASER ALIGNMENT. THIS WAS INDEPENDENT TO THE FLUID LEAK. NO FURTHER EVIDENCE OF FLUID LEAK WAS OBSERVED. THE INSTRUMENT CONFORMED TO THE MANUFACTURER'S PUBLISHED PERFORMANCE SPECIFICATIONS AND WAS RETURNED TO NORMAL OPERATION. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED APPROXIMATELY TWENTY-FIVE (25) MILLILITERS OF CLEAR FLUID LEAKED UNDER THE RIGHT SIDE OF THE INSTRUMENT AND ON THE COUNTER, AND THE ROCKER SENSOR WAS NOT FUNCTIONING, INVOLVING THE COULTER LH 750 HEMATOLOGY ANALYZER. THE OPERATOR WAS WEARING PROPER PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF GLOVES, A LABORATORY COAT, AND EYE PROTECTION AND DID NOT HAVE DIRECT CONTACT WITH THE FLUID. THERE WAS NO OPERATOR INJURY OR ADVERSE EFFECT ASSOCIATED WITH THIS EVENT. NO ERRONEOUS PATIENT RESULTS WERE GENERATED. THERE WAS NO PATIENT CONSEQUENCE ASSOCIATED WITH THIS EVENT. THE FACILITY HAS AN EXPOSURE CONTROL OR RISK MANAGEMENT PLAN IN PLACE. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ASSESS THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283900 COULTER® LH 750 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1