FALL CARDIOPLEGIA PLUS FILTER WITH SOLUTION SPIKE

Additional Manufacturer Narrative

DEVICE EVALUATION BEGUN, BUT NOT YET COMPLETED. ADD'L LOT # 703902.

Description of Event or Problem

IT WAS REPORTED FROM A QA INTERNAL DEPT TO THE FIRM THAT PARTICLES WERE DISCOVERED IN THE DOWNSTREAM CHAMBER OF THE DEVICE DURING A POST-SHIPMENT INSPECTION. THE DEVICES HAD NOT BEEN DISPATCHED TO A CUSTOMER.

Additional Manufacturer Narrative

THE MODEL NUMBER AND/OR CATALOG NUMBER OF THE DEVICE LISTED IN THE MEDICAL DEVICE REPOR THE FINAL RESULTS OF ANY FAILURE ANALYSIS OR LABORATORY TESTING OF THE DEVICE LISTED IN THE REPORT(S) INCLUDING: A COMPLETE DESCRIPTION OF METHODOLOGY(IES) USED, AN IDENTIFICATION OF THE FAILURE MODE(S) AND/OR MECHANISM(S) AND THE ASSOCIATED COMPONENTS(S) INVOLVED, ANY CONCLUSIONS BASED ON THE FINAL FAILURE ANALYSIS OR LABORATORY TEST RESULTS. THE METHODOLOGIES USED IN THE FAILURE ANALYSIS WERE VISUAL EXAMINATION OF THE DEVICE, REVIEW OF THE DEVICE HISTORY RECORDS AND MANUFACTURING EQUIPMENT MAINTENANCE RECORDS. THE FAILURE MODE WAS IDENTIFIED AS RELATED TO THE MEDIA CUTTING OPERATION AND THE END-CAPPING OPERATION, AND POSSIBLY THE VISUAL INSPECTION PROCESS. NO SPECIFIC ROOT CAUSE WITHIN THOSE OPERATION STAGES WAS IDENTIFIED. A COPY OF ALL CURRENT LABELING FOR THE DEVICE, INCLUDING DIRECTIONS FOR USE, CAUTION STATEMENTS, TECHNICAL MANUALS, AND PRODUCT PERFORMANCE REPORTS. LABELING IS INCLUDED AS A SEPARATE ATTACHMENT TO THE EMAIL DESCRIPTION OF ANY DESIGN CHANGES OR MODIFICATIONS IN THE DEVICE SINCE FIRST MARKETED THAT MAY BE RELATED TO THE EVENT INCLUDING ANY STERILIZATION CHANGES, IF APPLICABLE, AND THE DATE OF THE CHANGES. THERE APPEAR TO BE NO DESIGN CHANGES IN THE DEVICE SINCE FIRST MARKETED THAT MAY BE RELATED TO THE EVENT. THE PRODUCT WAS NOT DISTRIBUTED STERILE. IT IS UNLIKELY THE CUSTOMER'S STERILIZATION PROCESS CONTRIBUTED TO THE EVENT. PLEASE PROVIDE THE TOTAL NUMBER OF DEVICES MANUFACTURED AND DISTRIBUTED FOR THE LAST THREE YEARS BY YEAR FOR THE DEVICE INDICATED IN THE MEDICAL DEVICE REPORT. (UNITS DISTRIBUTED TO END-CUSTOMERS GLOBALLY): YEAR ; 2005, 2006, 2007. PLEASE PROVIDE LABELING IN AN ELECTRONIC FORMAT. YOU CAN E-MAIL YOUR RESPONSE AND LABELING. WE HAVE RECEIVED SEVERAL COMPLAINTS OF PARTICLES. HOW MANY TOTAL COMPLAINTS HAVE YOU RECEIVED? PLEASE ALSO PROVIDE A BREAKDOWN BY YEAR. FOR THE PRODUCT FAMILY: THERE HAVE 4 TOTAL COMPLAINTS RELATED TO PARTICLES AND MDR. MDR NO, DATE OF EVENT: 2647898-2006-00003, 2006;2647898-2007-00008, 2007; 2647898-2007-00009, 2007; 2647898-2007-00010, 2007. THERE HAVE BEEN NO SIMILAR COMPLAINTS RELATED TO MDRS IN THE 12 MONTHS SINCE THE LAST MDR LISTED ABOVE. IN THE EVALUATION SECTION, PROVIDE THE ROOT CAUSE AND ANY ACTIONS TAKEN. NO SPECIFIC ROOT CAUSE WAS IDENTIFIED. HOWEVER A GENERAL CORRECTIVE ACTION PLAN TO REDUCE THE LEVEL OF MANUFACTURING PARTICULATES WAS APPLIED TO THIS PRODUCT FAMILY. WHERE IS THIS DEVICE MANUFACTURED? THE DEVICE IS MANUFACTURED AT ESTABLISHMENT. WHERE IS IT STERILIZED AND PACKAGED? THE DEVICES IN THESE REPORTS (CPS02NS) ARE SUPPLIED NON-STERILE, TO ANOTHER MANUFACTURER WHO INCORPORATED THE DEVICE IN TUBING PACKS AND STERILIZES THE TUBING PACKS PRIOR TO DELIVERY TO END-USER FACILITIES. UNLESS SUBSTANTIALLY SIGNFICANT INFORMATION BECOMES AVAILABLE, THIS CONSTITUTES A FINAL REPORT.