BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 780 HEMATOLOGY ANALYZER

    MDR report key: 3002999 · Received March 13, 2013

    Report

    Report Number
    1061932-2013-00383
    Event Type
    Malfunction
    Date Received
    March 13, 2013
    Date of Event
    February 15, 2013
    Report Date
    February 15, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K061616
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WENT ON-SITE AND CONFIRMED A FLUID LEAK BY THE FLOW CELL AND THERE WERE RETIC R CODES WHILE RUNNING CONTROLS. FSE REPLACED THE SAMPLE LINE AT THE BOTTOM OF THE FLOW CELL AND LATER FOUND THAT THE TUBING HAD A SHARP TWIST. THE FLOW CELL OUTPUT WAS FLUSHED TO THE DIFFERENTIAL WASTE CHAMBER ALONG WITH THE DIFFERENTIAL WASTE CHAMBER VENT SYSTEM. NO FURTHER LEAKS WERE OBSERVED AND FSE WAS ABLE TO RUN CONTROLS TWICE WITHOUT ANY R CODE FLAGS. THE CAUSE OF THE LEAK IS ATTRIBUTED TO A SHARP BEND IN THE TUBING AT THE BOTTOM OF THE FLOWCELL. SUBSEQUENT RECOVERY OF INCOMPLETE DIFFERENTIAL RESULTS FOLLOWED BY INCOMPLETE RETIC RESULTS, ALERTED THE OPERATOR TO AN INSTRUMENT PROBLEM. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER TO REPORT A FAINT RED LEAK OF ABOUT 6-10 ML ORIGINATING FROM THE RIGHT SIDE OF A COULTER LH 780 HEMATOLOGY ANALYZER NEAR THE FLOWCELL. THE LEAK WAS NOT CONTAINED WITHIN THE INSTRUMENT. THE CUSTOMER REPORTED THAT THE INSTRUMENT DID NOT GENERATE DIFFERENTIAL RESULTS FOR THE SAMPLES BEING RUN. THE OPERATOR WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF A LAB COAT AND GLOVES AT THE TIME OF THE EVENT. NO INJURY OR EXPOSURE WAS REPORTED. NO ERRONEOUS RESULTS WERE GENERATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106115 COULTER® LH 780 HEMATOLOGY ANALYZER AUTOMATED DIFFERENTIAL CELL COUNTER GKZ BECKMAN COULTER LH 780 NA

    Patients

    Seq Age Sex Outcome Treatment
    1