BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELL-DYN 1800 ANALYZER

    MDR report key: 1060034 · Received June 12, 2008

    Report

    Report Number
    2919069-2008-00602
    Event Type
    Malfunction
    Date Received
    June 12, 2008
    Date of Event
    May 22, 2008
    Report Date
    May 22, 2008
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION/CELLDYN
    Product Code
    GKZ
    PMA / PMN Number
    K030513
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    MEDICAL ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS AN INITIAL REPORT. AN INVESTIGATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION, RESULTS: PRODUCT MEETS RELIABILITY DATA. ABBOTT LABORATORIES RECEIVED AN INITIAL CUSTOMER COMPLAINT ALLEGING THE CELL-DYN INSTRUMENT DID NOT SIGNAL A WASTE FULL ALARM. ALTHOUGH THE ORIGINAL PART FOR THIS EVENT COULD NOT BE INVESTIGATED, THE INVESTIGATION OF THE REPORTED ISSUE DETERMINED THAT THE PART WAS IN USE GREATER THAN 2 YEARS. THE INVESTIGATION INTO RETURNED PARTS FROM THE FIELD SHOWED THAT ALL HAVE BEEN IN USE GREATER THAN 2 YEARS. IN-HOUSE INVESTIGATION OF THE RETURNED PARTS COULD NOT REPRODUCE THE OCCURRENCE OF THE INITIAL COMPLAINT. THERE EXISTS A POTENTIAL FOR THE WASTE CONTAINER TO OVERFLOW WITH LIQUID WASTE WHEN THE WASTE SENSOR FAILS AT THE END OF ITS LIFE CYCLE. THE WASTE OUTLET TUBE ASSEMBLY (LN 92161-02) HAS A LONG HISTORY OF BEING RELIABLE. THERE HAVE BEEN NO TRENDS IN THE PERFORMANCE OF THIS PART FROM A RELIABILITY PERSPECTIVE. IT HAS CONSISTENTLY MET RELIABILITY EXPECTATIONS. THE WASTE OUTLET TUBE ASSEMBLY HAS BEEN ON THE MARKET FOR OVER 10 YEARS, AND MEETS RELIABILITY EXPECTATIONS FOR THE CELL-DYN 1800 INSTRUMENT. IT CAN BE USED ON MULTIPLE CELL-DYN INSTRUMENT MODELS. A REVIEW OF THE CELL-DYN 1800 SYSTEM OPERATORS MANUAL, LIST NUMBER 07H80-01, REVISION E, SHOWED ADEQUATE COVERAGE OF BIOHAZARD EXPOSURE AND WASTE OVERFLOW AS WELL AS TROUBLESHOOTING INFORMATION. THE WASTE OUTLET TUBE ASSEMBLY IS PERFORMING AS DESIGNED. THE RELIABILITY WAS DETERMINED TO BE ACCEPTABLE, AND THE PRODUCT IS MEETING EXPECTED SAFETY PERFORMANCE AS ESTABLISHED IN THE PRODUCT RISK MANAGEMENT FILE. ALTHOUGH THE WASTE OUTLET TUBE ASSEMBLY MEETS THE RELIABILITY REQUIREMENT, THERE EXISTS A POTENTIAL FOR THE WASTE CONTAINER TO OVERFLOW WITH LIQUID WASTE IF THE PRODUCT FAILS AT THE END OF ITS LIFE EXPECTANCY. THIS IS THE FINAL REPORT.

    Description of Event or Problem · 1

    THE ACCOUNT STATED THAT THE CELL-DYN 1800 ANALYZER IS GENERATING CONTINUOUS WBC CLOG ERRORS. FIELD SVC WAS REQUESTED AND STATED THAT THE WASTE OUTLET TUBE ASSEMBLY WIRES WERE VISUALLY BROKEN. THE ISSUE WAS RESOLVED BY REPLACING THE WASTE TUBE OUTLET ASSEMBLY. THERE WAS NO DIRECT EXPOSURE OR INJURY REPORTED FOR THIS ISSUE AND NO IMPACT TO PT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CELL-DYN 1800 ANALYZER AUTOMATED HEMATOLOGY ANALYZER GKZ ABBOTT DIAGNOSTICS DIVISION/CELLDYN NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI WASTE OUTLET TUBE, LIST 92161-02 LOT UNK| WASTE OUTLET TUBE, LIST # 926161-02 LOT# UNK