BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 500 HEMATOLOGY ANALYZER

    MDR report key: 2990810 · Received March 5, 2013

    Report

    Report Number
    1061932-2013-00334
    Event Type
    Malfunction
    Date Received
    March 5, 2013
    Date of Event
    January 31, 2013
    Report Date
    February 5, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K042724
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED SYSTEM AMBIENT TEMPERATURE ERRORS AFTER PERFORMING SYSTEM SHUTDOWN INVOLVING THE COULTER LH 500 HEMATOLOGY ANALYZER. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) EVALUATED THE INSTRUMENT AT THE LABORATORY AND OBSERVED PELTIER TEMPERATURE ERRORS WHICH RESULTED FROM THE TUBING THAT CAME OFF AT PINCH VALVE PV43. THE FLUID LEAK DAMAGED THE LIGHT SCATTER (LS) PREAMP AND PELTIER TEMP CARD. THE FSE REPLACED THE TUBING AND THE LS PREAMP TO RESOLVE THE AMBIENT TEMPERATURE ERRORS. THE FSE ALSO OBSERVED A FLUID LEAK FROM THE I-BEAM TUBING AT PINCH VALVE PV37. THE FSE REPLACED THE I-BEAM TUBING AND RESOLVED THE FLUID LEAK ISSUE. SERVICE ACTIVITY PERFORMED WAS VERIFIED TO MEET THE SPECIFIED REQUIREMENTS PER ESTABLISHED PROCEDURES. THERE WAS NO INJURY OR ADVERSE EFFECT ASSOCIATED WITH THE FLUID LEAK. THE CUSTOMER HAD ON PERSONAL PROTECTIVE EQUIPMENT (PPE) AT THE TIME OF THE EVENT. PATIENT RESULTS WERE NOT IMPACTED. THE LABORATORY HAS AN EXPOSURE CONTROL/RISK MANAGEMENT PLAN IN PLACE. THE INSTRUMENT WAS RETURNED TO NORMAL OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93580 COULTER® LH 500 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1