BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELL-DYN 3700 SL ANALYZER

    MDR report key: 1171529 · Received September 17, 2008

    Report

    Report Number
    2919069-2008-00695
    Event Type
    Malfunction
    Date Received
    September 17, 2008
    Date of Event
    August 29, 2008
    Report Date
    August 29, 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
    IT
    Reporter Occupation
    UNKNOWN

    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

    INVESTIGATION PLAN/SUMMARY: THE POWER SUPPLY WAS EVALUATED AND IT WAS FOUND THAT THE FILTER CAPACITOR C4 IN THE +12V-UNREGULATED PORTION OF THE POWER SUPPLY HAD RUPTURED. THE TERMINAL LUG AND THE TRANSFORMER SECONDARY WIRE HAD MELTED OFF OF THE BRIDGE RECTIFIER. THE INSULATION OF THE TRANSFORMER ON BOTH PRIMARY AND SECONDARY WIRES HAD ALSO MELTED OFF. THE POWER SUPPLY WAS SET UP FOR 240V 50HZ OPERATION AND THE PRIMARY FUSE, WHICH IS USED IN THIS POWER SUPPLY, WAS MISSING WHEN RETURNED FOR EVALUATION. THE POWER SUPPLY IS SOLD AS A FIELD REPLACEABLE UNIT (FRU) UNDER PART NUMBER FOR USE WITH THE CELL-DYN 3000, CELL-DYN 3500, AND CELL-DYN 3700. 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 SUPPLY IS A POTENTIAL SOURCE OF FIRE. CONTROLS IN PLACE TO REDUCE THE RISK ARE OVER-CURRENT PROTECTION, FUSING, SAFETY ICONS, AND HAZARD WARNING LABELS. THE CELL-DYN 3700 INSTRUMENT, LIST NUMBER 02H31-01 AND SERIAL NUMBER, WAS INSTALLED AT THE ACCOUNT IN 2005. NO PREVENTIVE MAINTENANCE HAS BEEN PERFORMED ON THE INSTRUMENT SINCE INSTALLATION. PRIOR TO THIS CALL, NO OTHER PARTS HAVE BEEN REPLACED ON THIS INSTRUMENT. THE EVENT IS ADDRESSED IN LABELING. CELL-DYN 3700 SYSTEM OPERATOR'S MANUAL, LIST NUMBER 06H89-01, REVISION F: SECTION 10: TROUBLESHOOTING GUIDE, PAGE 10-30. BASED ON THE INVESTIGATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED FOR THE CELL-DYN 3700 INSTRUMENT. 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

    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.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE CELL-DYN 3700 ANALYZER CAUGHT FIRE NEAR THE CABLE TO THE POWER SUPPLY. NO IMPACT TO PATIENT MANAGEMENT OR INJURY WAS REPORTED DUE TO THIS ISSUE. SERVICE REPLACED THE POWER SUPPLY TO RESOLVE THE ISSUE.

    Description of Event or Problem · 1

    ON 10/06/09, DURING DEVICE EVALUATION BY BAXTER THE PUMP HEAD MODULE KEYPAD STOP BUTTON ON A COLLEAGUE VOLUMETRIC INFUSOR PUMP-SINGLE CHANNEL WAS FOUND TO BE INOPERATIVE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED RELATED TO THIS DEVICE. THE PUMP HAS BEEN FORWARDED TO BAXTER PUMP ANALYSIS LAB FOR FURTHER TESTING. THIS DEVICE UTILIZES USER INTERFACE MODULE MASTER SOFTWARE (B) (4), CATEGORIZED AS UNREMEDIATED.

    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 NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA