BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM

    MDR report key: 4439680 · Received January 22, 2015

    Report

    Report Number
    1061932-2015-00109
    Event Type
    Malfunction
    Date Received
    January 22, 2015
    Date of Event
    December 31, 2014
    Report Date
    December 31, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K140911
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) EVALUATED THE INSTRUMENT ON 12/31/2014. THE FIELD SERVICE ENGINEER (FSE) FOUND A LEAK THROUGH TUBING AT PORT 9 ON MANIFOLD MF202 (VOLUME CONDUCTIVITY SCATTER (VCS) FLOW CONTROL MANIFOLD). THE FSE REATTACHED THE TUBING, WHICH REPAIRED THE LEAK. THE REPAIRS WERE VERIFIED PER ESTABLISHED PROCEDURES. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A LEAK FROM THE RIGHT SIDE OF THE UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM DURING A MAINTENANCE PROCEDURE. THE CUSTOMER WAS UNABLE TO LOCATE THE EXACT LOCATION OF THE LEAK. THE VOLUME OF THE LEAK IS UNKNOWN AND WAS CONTAINED WITHIN THE INSTRUMENT. THE CUSTOMER DID NOT REPORT ANY ERROR MESSAGES FROM THE INSTRUMENT AT THE TIME OF THE EVENT. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF GLOVES, EYE PROTECTION AND A LABORATORY COAT AT THE TIME OF THE OCCURRENCE AND THERE WAS NO REPORT OF INJURY OR DIRECT EXPOSURE TO THE LEAK. ERRONEOUS PATIENT RESULTS WERE NOT GENERATED AND THERE WAS NO CHANGE OR AFFECT TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    51924 UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1