BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CYTOMICS FC 500 MPL FLOW CYTOMETER

    MDR report key: 3834066 · Received May 27, 2014

    Report

    Report Number
    1061932-2014-01172
    Event Type
    Malfunction
    Date Received
    May 27, 2014
    Date of Event
    April 29, 2014
    Report Date
    April 29, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K071681
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) REPLACED THE CRACKED LEE VALVE DUE TO UNSTABLE PRESSURE ISSUE. NO FURTHER EVIDENCE OF FLUID LEAKS WAS OBSERVED AFTER THE VALVE REPLACEMENT. THE INSTRUMENT CONFORMED TO THE MANUFACTURER'S PUBLISHED PERFORMANCE SPECIFICATIONS AND WAS RETURNED TO NORMAL OPERATION. IN CONCLUSION, THE LIKELY CAUSE OF THE EVENT IS ATTRIBUTED TO THE CRACKED LEE VALVE. A DEFINITIVE CAUSE OF THE CRACKED VALVE IS UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    THE AFFILIATE STATED THE CUSTOMER REPORTED THE LEE VALVE LEAKED APPROXIMATELY 20 MILLILITERS OF FLUID AFTER THE VALVE WAS REPLACED WITHIN ONE WEEK INVOLVING THE CYTOMICS FC500 MPL FLOW CYTOMETER. THE OPERATOR WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF GLOVES AND A LABORATORY COAT AND DID NOT HAVE DIRECT CONTACT WITH THE FLUID. THERE WAS NO OPERATOR INJURY OR ADVERSE EFFECT ASSOCIATED WITH THIS EVENT. PATIENT RESULTS WERE NOT IMPACTED. THERE WAS NO PATIENT CONSEQUENCE ASSOCIATED WITH THIS EVENT. THE CUSTOMER INDICATED THE FACILITY HAS AN EXPOSURE CONTROL AND RISK MANAGEMENT PLAN IN PLACE FOR BIOHAZARD MATERIAL. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ASSESS THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311525 CYTOMICS FC 500 MPL FLOW CYTOMETER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1