BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELL-DYN 3700 SL ANALYZER

    MDR report key: 1232730 · Received November 18, 2008

    Report

    Report Number
    2919069-2008-00785
    Event Type
    Malfunction
    Date Received
    November 18, 2008
    Report Date
    April 7, 2008
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION/CELLDYN
    Product Code
    GKZ
    PMA / PMN Number
    K980614
    Removal / Correction Number
    2919069-3/31/09-002-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AN INVESTIGATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE INVESTIGATION OF THE CELL-DYN 3700 ANALYZER SMOKE AND FIRE ISSUE IDENTIFIED THE ROOT CAUSE AS THE INSTALLATION OF AN INCORRECT FUSE (BY EITHER THE CUSTOMER OR THE FIELD SERVICE REPRESENTATIVE) IN THE ANALYZER POWER SUPPLY WHEN IT IS OPERATED AT 220/240 VAC (VOLTS ALTERNATING CURRENT), WHICH MAY RESULT IN THE POSSIBILITY OF SMOKE AND FIRE. THE CELL-DYN 3700 OPERATOR'S MANUAL CONTAINS THE ELECTRICAL REQUIREMENTS AND SPECIFIC VOLTAGE SETTINGS FOR EACH SYSTEM. THERE ARE ALSO CONTROLS IN PLACE TO REDUCE THE RISK OF SMOKE AND FIRE (OVER-CURRENT PROTECTION, FUSING, SAFETY ICONS AND HAZARD WARNING LABELS). THE FOLLOWING STEPS WERE PUT IN PLACE TO CORRECT THIS ISSUE: A PRODUCT INFORMATION LETTER WAS ISSUED ON (B)(6) 2009 TO EMPHASIZE TO NEW CUSTOMERS TO FOLLOW THE INSTRUCTIONS PROVIDED IN THE CELL-DYN 3700 SYSTEM OPERATOR'S MANUAL FOR FUSE REPLACEMENT. A FIELD COMMUNICATION (PRODUCT CORRECTION) WAS ISSUED ON (B)(6) 2009 TO ALL AFFECTED CUSTOMERS TO ENSURE THAT THE CORRECT FUSE WAS INSTALLED IN THE CELL-DYN 3700 ANALYZERS IN THE FIELD. MANUFACTURING INSTRUCTIONS WERE CHANGED TO REMOVE THE FUSE PRIOR TO SHIPPING OF THE PRODUCT TO REDUCE THE RISK OF AN INCORRECT FUSE BEING INSTALLED. INSTRUCTIONS WERE PROVIDED TO THE FIELD SERVICE PERSONNEL THROUGH AN INSTALLATION CHECK LIST TO VERIFY THAT THE CORRECT FUSE WAS INSTALLED DURING INSTALLATION. FURTHERMORE, THE PREVENTIVE MAINTENANCE PROCEDURE WAS CHANGED TO INCLUDE A CHECK THAT THE CORRECT FUSE WAS INSTALLED.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    IN 2008, THE CUSTOMER REPORTED THAT SMOKE WAS COMING FROM THE POWER SUPPLY OF THE CELL-DYN 3700 INSTRUMENT. A FIELD SERVICE REPRESENTATIVE REPLACED THE POWER SUPPLY AND RETURNED THE INSTRUMENT INTO OPERATIONAL STATUS. THE POWER SUPPLY WAS DISCARDED. THE CTA CONFIRMED THROUGH THE CUSTOMER ON THE SAME DAY THAT THE SMOKE WAS COMING FROM AN EXTENSION CORD WHERE THE INSTRUMENT HAD BEEN TEMPORARILY CONNECTED. THE EXTENSION CORD SHORT-CIRCUITED, CREATED THE SMOKE, AND BURNED THE POWER SUPPLY. THE CELL-DYN 3700 SYSTEM OPERATOR'S MANUAL PROVIDES INSTRUCTIONS FOR SHUTTING DOWN THE INSTRUMENT AND STATES THAT IN AN EMERGENCY SITUATION, TO TURN OFF THE POWER SWITCHES, IN ANY ORDER, AS QUICKLY AS POSSIBLE. FOLLOW THE POWER ON PROCEDURE AS DESCRIBED EARLIER IN THIS SECTION (SECTION 10) WHEN THE EMERGENCY IS OVER. THE COMPLAINT ANALYSIS TRENDING SYSTEM (CATS) AND TRENDING ANALYSIS SUPPORT SYSTEM (TASS) REPORTS WERE REVIEWED AND NO ADVERSE TRENDS WERE IDENTIFIED. NO MALFUNCTION WAS IDENTIFIED. THE ISSUE WAS ATTRIBUTED TO THE EXTENSION CORD. THIS IS THE FINAL REPORT.

    Description of Event or Problem · 1

    THE CELL-DYN 3700 SL ANALYZER WAS GENERATING SMOKE FROM THE POWER SUPPLY. THE POWER SUPPLY WAS REPLACED. NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CELL-DYN 3700 SL ANALYZER AUTOMATED HEMATOLOGY ANALYZER GKZ ABBOTT DIAGNOSTICS DIVISION/CELLDYN

    Patients

    Seq Age Sex Outcome Treatment
    1