IT WAS REPORTED THAT AN AIR ASPIRATION LEAK WAS DETECTED WHILE USING THE DEVICE IN 2007, WHILE A TECHNICIAN WAS PERFORMING A ROUTINE READING ON ONE SAMPLE POUCH. THE TECHNICIAN OBSERVED THAT THE SAMPLE POUCH APPEARED TO HAVE TOO MUCH AIR REMAINING AFTER TWO GAS SAMPLES WERE WITHDRAWN FOR TESTING. THE TECHNICIAN THEN PROCEEDED TO PERFORM A LEAK TEST AND DISCOVERED A SAMPLE HOSE LEAK. THE USER FACILITY THEN CONDUCTED A REVIEW OF PREVIOUS TEST DATA PRODUCED BY THE DEVICE AND CONCLUDED THAT THE HOSE LEAK HAD GONE UNDETECTED SINCE OCTOBER 2006. THE OXYGEN CONCENTRATIONS OF SAMPLES TESTED DURING THE MONTHS PRECEDING THIS OBSERVATION WERE RUNNING AT APPROXIMATELY 20% O2. CUSTOMER ALSO MENTIONED THAT THE HOSE ASSEMBLY WAS REPLACED AND THAT THE FACILITY NOW PERFORMS A LEAK TEST BEFORE EACH RUN. NO ADVERSE CLINICAL EVENTS WERE REPORTED IN PATIENTS RECEIVING PLATELET TRANSFUSIONS DURING THE TIME INTERVAL REPORTED ABOVE.
N
Patient 1
DEVICE EVALUATION STARTED, BUT NOT YET COMPLETED.
N
Patient 1
THE REPORTER?S CONCLUSION THAT THE ABNORMAL VOLUME OF AIR REMAINING IN THE SAMPLE POUCH WAS RELATED TO AN AIR LEAK (INGRESS) INTO THE GAS SAMPLING SYSTEM COULD NOT BE DIRECTLY CONFIRMED BECAUSE THE EBDS OXYGEN ANALYZER WITH ATTACHED SAMPLING TUBE WAS NOT RETURNED TO US. THE FACT THAT A REPLACEMENT OF THE SAMPLE TUBE ASSEMBLY RESULTING IN INSTRUMENT PERFORMANCE THAT DID NOT LEAVE ABNORMAL VOLUMES OF GAS IN THE SAMPLING POUCH IS CONSISTENT WITH THE DIAGNOSIS OF THE AIR-LEAK FAULT MADE BY THE USER FACILITY. IT WAS NOTED THAT THE VERSION OF OXYGEN ANALYZER ORIGINALLY REPORTED WAS NOT CORRECT: THE INSTRUMENT IN USE WAS VERIFIED FROM SHIPMENTS AND ITS SERIAL NUMBER. THE POTENTIAL FOR AIR LEAKAGE INTO THE GAS SAMPLING SYSTEM HAD BEEN EVIDENCED SEVERAL YEARS PREVIOUS TO THIS EVENT IN PREVIOUS REPORTS: 2013342-2004-00005, 2013342-2004-00006 AND 2013342-2004-00007 ENHANCEMENT TO THE SYSTEM, INCLUDING A MORE ROBUST GAS SAMPLE ASSEMBLY AND EBDS SYSTEM SELF-TEST FOR THE LEAKAGE WAS INTRODUCED AS A HARDWARE AND SOFTWARE MODIFICATION. NOTICES FOR THESE IMPROVEMENTS AND RECOMMENDATIONS FOR LEAK TESTING WERE SENT TO CUSTOMERS, AND INCLUDED IN SUBSEQUENT EDITIONS OF THE PRODUCT LABELING (USER GUIDE). THE DATALOG, GENERATED FROM THE INSTRUMENTS INTERNAL DATA-MONITORING, PROVIDED BY THE CUSTOMER WAS FOR THE MONTH OF MAY 2007 SUBSEQUENT TO THE EVENT AND CHANGE OUT OF SAMPLING SET, AND THEREFORE WAS NOT USEFUL IN DETERMINING WHETHER THE STATE OF LEAKAGE MAY HAVE CAUSED THE TESTING TO REPORT ANY FALSE-NEGATIVE RESULTS. THE ABSENCE OF ANY CLINICAL REPORTS OF INFECTION-RELATED SYMPTOMS IS CONSISTENT WITH THE SUPPOSITION THAT NO FALSE NEGATIVE DETERMINATIONS OCCURRED DURING THE PERIOD PRIOR TO THE CHANGE-OUT OF SAMPLE GAS ASSEMBLY, AND INSTITUTION OF REGULAR LEAK TESTING. NO FALSE NEGATIVE REPORTS, AIR-IN POUCH, OR SYSTEM LEAKS REPORTS HAVE BEEN REPORTED FROM THE USER FACILITY IN THE ELEVEN MONTHS FOLLOWING THE INITIAL REPORT. SUMMARY: THE USER REPORT OF MALFUNCTION APPEARS TO BE RELATED TO FAILURE BY THE USER TO INSTITUTE A RECOMMENDED MAINTENANCE PROGRAM TO CHANGE SAMPLE GAS TUBING PERIODICALLY, AND TO PERFORM PERIODIC LEAK TESTS. FALSE NEGATIVES RELATED TO LEAKS IN THE SYSTEM HAVE NOT BEEN REPORTED FROM OTHER USERS IN THE PAST THREE YEARS OR FROM THE REPORTING FACILITY SINCE THE MANUFACTURER?S RECOMMENDATIONS WERE IMPLEMENTED. THERE APPEAR TO HAVE BEEN NO CLINICAL SEQUELAE RELATED TO THIS MALFUNCTION REPORT. UNLESS SUBSTANTIALLY SIGNIFICANT INFORMATION BECOMES AVAILABLE THIS CONSTITUTES A FINAL REPORT.