BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD1800 ANALYZER

    MDR report key: 1032653 · Received April 22, 2008

    Report

    Report Number
    2919069-2008-00512
    Event Type
    Malfunction
    Date Received
    April 22, 2008
    Date of Event
    March 24, 2008
    Report Date
    March 24, 2008
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION / CELL DYN
    Product Code
    GKZ
    PMA / PMN Number
    K030513
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER TECHNICAL ADVOCATE (CTA) HAD THE CUSTOMER CHECK THE WASTE TUBING ASSEMBLY AND RECOMMENDED THAT THE TWO SENSOR PRONGS BE CLEANED. THE CUSTOMER FOUND THERE WAS ONLY ONE PRONG PRESENT BELOW THE CAP. THE CTA DETERMINED THAT THE WASTE OUTLET TUBING ASSEMBLY NEEDED REPLACEMENT TO RESOLVE THE ISSUE AND A REPLACEMENT WAS ORDERED FOR THE CUSTOMER. LABELING: CELL-DYN SYSTEM 1800 OPERATOR'S MANUAL, 07H80-01, REV D: SECTION 2 PROVIDES INFO ON WASTE ROUTING AND DISPOSAL. (2.5). A "CAUTION" NOTE APPEARS ON PAGE 2-5 AND 7-2 WHICH STATES: "THE WASTE IS UNDER PRESSURE. BE SURE THAT THE WASTE OUTLET TUBE IS SECURELY PLACED IN THE DRAIN HOLE OR WASTE BOX, FLOW OF WASTE IS UNOBSTRUCTED, AND ALL INSTRUMENT COMPONENTS ARE LOCATED AWAY FROM POSSIBLE WASTE OVERFLOW". SECTION 9 SHOWS "EMPTY WASTE" AS AN "AS-NEEDED" ACTIVITY. HOWEVER DAILY START-UP PROCEDURE AND DAILY SHUTDOWN PROCEDURE HAVE CHECKLISTS, WHICH INCLUDE DIRECTIONS TO EMPTY WASTE AS NEEDED. (9-15, 9-16). SECTION 10, UNDER OBSERVED OR MECHANICAL ERRORS OR CONDITIONS, ADDRESSES THE ISSUES OF WASTE OVERFLOW OR WASTE FULL WITH NO MESSAGE DISPLAYED. (10-29). A REVIEW OF THE COMPLAINT ANALYSIS TRENDING SYSTEM (CATS) AND TRENDING ANALYSIS SUPPORT SYSTEM (TASS) REPORTS, FOR THE PERIOD JULY 2007 THROUGH FEBRUARY 2008, DID NOT INDICATE ANY ADVERSE TREND WITH THE CELL-DYN 1800, LIST BASE 07H77-01, FOR ISSUES WITH WASTE OVERFLOW. THERE WAS NO SYSTEMIC ISSUE. THIS IS THE FINAL REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER STATED A WASTE OVERFLOW OCCURRED WITH NO "WASTE FULL" WARNING GENERATED ON THE CELL-DYN 1800 ANALYZER. THE OPERATOR HAD NO DIRECT CONTACT WITH THE LIQUID WASTE AND NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CD1800 ANALYZER AUTOMATED HEMATOLOGY ANALYZER GKZ ABBOTT DIAGNOSTICS DIVISION / CELL DYN NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI