BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FALL CARDIOPLEGIA PLUS FILTER WITH SOLUTION SPIKE

    MDR report key: 867832 · Received June 20, 2007

    Report

    Report Number
    2647898-2007-00010
    Event Type
    Malfunction
    Date Received
    June 20, 2007
    Date of Event
    May 21, 2007
    Report Date
    May 23, 2007
    Manufacturer
    PALL LIFE SCIENCES PUERTO RICO, LLC
    Product Code
    JOD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FALL CARDIOPLEGIA PLUS FILTER WITH SOLUTION SPIKE JOD: CARDIOPULMONARY BYPASS CARDIOTOMY SUCTION LINE BLOOD FI JOD PALL LIFE SCIENCES PUERTO RICO, LLC CPS02 632102

    Patients

    Seq Age Sex Outcome Treatment
    1 YR