BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELL-DYN 3700 CS ANALYZER

    MDR report key: 1080268 · Received July 22, 2008

    Report

    Report Number
    2919069-2008-00640
    Event Type
    Malfunction
    Date Received
    July 22, 2008
    Date of Event
    July 2, 2008
    Report Date
    July 2, 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 Location
    OK, US
    Reporter Occupation
    OTHER

    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) OTHER : (B)(4) PRINTED CIRCUIT BOARD (PCB) FLOW CONTROL MODULES AND PRINTED CIRCUIT BOARD SOLENOID DRIVER MODULE. INVESTIGATION PLAN/SUMMARY: DURING A FIELD SERVICE REPRESENTATIVE (FSR) VISIT ON (B)(6) 2008, THE POWER SUPPLY, THE PRINTED CIRCUIT BOARD FLOW CONTROL MODULE (FCM) AND THE PRINTED CIRCUIT BOARD SOLENOID DRIVER (SMD) WERE REPLACED. THE INSTRUMENT WAS RETURNED INTO AN OPERABLE STATUS. THREE (3) PRINTED CIRCUIT BOARD (PCB) SOLENOID DRIVER MODULES (SDM), LIST NUMBERS 8960093001, REVISION A, AND ONE (1) PCB FLOW CONTROL MODULES (FCM), LIST NUMBER 8960132001, REVISION A, (B)(4), WERE RETURNED FOR INVESTIGATION ON (B)(6) 2008. THE POWER SUPPLY, LIST NUMBER 8921168202, REVISION E, (B)(4), WAS RETURNED FOR EVALUATION ON (B)(6) /2008. THE INVESTIGATION FOUND THAT TWO (2) OUT OF THE THREE (3) PRINTED CIRCUIT BOARD FLOW CONTROL MODULES HAD NO PROBLEM; THE THIRD FCM WAS BURNED ON THE TOP SIDE PORTION. THE PCB SDM HAD BURNED SPOTS ON THE TOP AND BOTTOM SIDES. EVALUATION OF THE RETURNED POWER SUPPLY SHOWED THAT THE BRIDGE RECTIFIER WAS DAMAGED. MEASUREMENT OF THE RESISTANCE BETWEEN THE WHITE CABLE TO THE BLACK CABLE WAS 0.3 OHM, WHICH INDICATED THAT THE RESISTANCE HAD SHORTED (NORMAL RESISTANCE SHOULD BE APPROXIMATELY 2.2 OHM). THE F2 FUSE SOCKET WAS MISSING FROM THE RETURNED UNIT AND THE F1 FUSE SOCKET WAS OPENED (BURNED). THE 8-AMP FUSE IN THE AC INLET SITE OF THE POWER SUPPLY WAS MISSING FROM THE RETURNED UNIT. THE INVESTIGATION SHOWED THAT THE PCB SDMS, THE PCB FCM, AND THE POWER SUPPLY SHORT CIRCUIT CAUSED THE BURNING SMELL AND SMOKE FROM THE CELL-DYN 3700 INSTRUMENT; HOWEVER, WHICH PART STARTED THE BURNING IS INCONCLUSIVE. THE CELL-DYN 3700 SYSTEM OPERATOR'S MANUAL (LIST NUMBER 06H89-01, REVISION F) UNDER SECTION 10, TROUBLESHOOTING GUIDE, PAGE 10-30, NOTES THAT IN AN EMERGENCY SITUATION, TO TURN OFF THE POWER SWITCHES, IN ANY ORDER, AS QUICKLY AS POSSIBLE. THE RISK MANAGEMENT FILE (RMF) FOR THE CELL-DYN 3700 (CELL-DYN 3700 RISK ANALYSIS V2.15) UNDER THE CD3700 RISK ANALYSIS TABLE, ITEM 7.01, PAGE 38, INDICATES THAT THE POWER SUPPLIES, MOTORS, AND SOLENOIDS AREA POTENTIAL SOURCE OF FIRE. CONTROLS IN PLACE TO REDUCE THE RISK ARE OVER-CURRENT PROTECTION, FUSING, SAFETY ICONS, AND HAZARD WARNING LABELS. A REVIEW OF COMPLAINT REPORTS, FOR THE PERIOD (B)(6) 2007 THROUGH (B)(6) 2008, DID NOT INDICATE ANY ADVERSE TREND FOR THE CELL-DYN 3700, LIST BASE 02H31-01 (INCLUDES L/N 02H30-01), FOR THE REPORTED ISSUE. BASED ON THE INVESTIGATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED FOR THE CELL-DYN 3700 INSTRUMENT FOR THE REPORTED ISSUE. AN EXPANDED INVESTIGATION HAS BEEN INITIATED TO DETERMINE THE CAUSE OF POWER SUPPLY FAILURES. THIS IS AN INTERIM REPORT, A FINAL REPORT WILL BE SENT AT THE COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    PRINTED CIRCUIT BOARD (PCB) FLOW CONTROL MODULES AND PRINTED CIRCUIT BOARD SOLENOID DRIVER MODULE. 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 20 MARCH 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 27 MAR 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.

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT THE CELL-DYN 3700 CS ANALYZER WAS IDLE AND BEGAN TO CYCLE BY ITSELF. IT WAS NOTICED THAT A BURNING SMELL AND SMOKE CAME FROM THE ANALYZER. NO FLAMES WERE OBSERVED. THE ANALYZER WAS TURNED OFF WITH NO INJURIES REPORTED DUE TO THIS ISSUE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA