BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 500 HEMATOLOGY ANALYZER

    MDR report key: 4112257 · Received September 23, 2014

    Report

    Report Number
    1061932-2014-02408
    Event Type
    Malfunction
    Date Received
    September 23, 2014
    Date of Event
    August 26, 2014
    Report Date
    August 26, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K042724
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER (BEC) FIELD SERVICE ENGINEER (FSE) WAS NOT DISPATCHED TO THE SITE FOR THIS EVENT. THE CUSTOMER BEGAN TO TROUBLESHOOT THE ISSUES WITH HELP FROM THE CUSTOMER TECHNICAL SUPPORT (CTS). THE CUSTOMER ATTEMPT TO BLEACH THE FLOW CELL AND THE CUSTOMER OBSERVED THE TUBING GOING THROUGH PINCH VALVE (PV28) WAS LEAKING. THE CUSTOMER REPLACED THE TUBING GOING THROUGH PINCH VALVE (PV28) BUT THE ISSUES DID NOT RESOLVED. SERVICE WAS SCHEDULE, BUT THE CUSTOMER CALLED THE CTS TO REPORT THAT THE LEAK WAS RESOLVED BY REPLACING THE TUBING AT PINCH VALVES (PV26 AND PV27). THE CUSTOMER PERFORMED QUALITY CONTROL (QC) WITHOUT ANY ERRORS. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED APPROXIMATELY 5 TO 10 CUBIC CENTIMETERS OF FLUID LEAKED UNDERNEATH THE COULTER LH 500 HEMATOLOGY ANALYZER. THE LEAK WAS NOT CONTAINED WITHIN THE INSTRUMENT. THE CUSTOMER STATED THAT THE DIFFS (DIFFERENTIALS) WERE VOTING OUT AND THE DIFF BACKGROUND IS +++. NO ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY. THERE WAS NO EXPOSURE TO MUCOUS MEMBRANES OR OPEN WOUNDS. THE OPERATOR WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF GLOVES AND A LAB COAT AT THE TIME OF THE OCCURRENCE. THERE WAS NO DEATH, INJURY, OR AFFECT TO USER OR CHANGE TO PATIENT TREATMENT ATTRIBUTED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    591695 COULTER LH 500 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1