OVERPRESSURE SAFETY VALVE

Additional Manufacturer Narrative

THIS FOLLOW-UP REPORT IS SUBMITTED TO FDA IN ACCORD WITH APPLICABLE REGULATIONS. UPON FURTHER INVESTIGATION OF THE REPORTED EVENT, THE FOLLOWING INFORMATION IS NEW AND/OR CHANGED: G3 (DATE RECEIVED BY MANUFACTURER) . G6 (INDICATION THAT THIS IS A FOLLOW-UP REPORT) . H2 (FOLLOW-UP DUE TO ADDITIONAL INFORMATION AND DEVICE EVALUATION) . H3 (DEVICE EVALUATED BY MANUFACTURER) . H6 (IDENTIFICATION OF EVALUATION CODES 10, 11, 3331, 4210, 25). THE RETURNED SAMPLE WAS INSPECTED UPON RECEIPT, AND NO VISUAL ANOMALIES WERE NOTED. OPS VALVES ARE SUBJECT TO A 100% LEAK TEST, WHICH INCLUDES FIVE DIFFERENT TESTS THE UNITS ARE RUN THROUGH TO ENSURE THERE ARE NO LEAKS AND BOTH THE UMBRELLAS AND DUCKBILLS ARE FUNCTIONING PROPERLY. THE SAMPLE WAS CONNECTED IN A CIRCULAR CIRCUIT AND PRESSURIZED WITH A SYRINGE TO 3.5 PSI WHILE SUBMERGED UNDER WATER TO TEST THE BODY OF THE OPS FOR LEAKS. THIS TEST FAILED INDICATING A BODY LEAK. UPON CLOSER INSPECTION, IT APPEARED TO LEAK FROM THE TOP OF THE UNIT, WHERE THE TWO HOUSINGS COME TOGETHER. A RETENTION SAMPLE OF THE SAME PART AND LOT NUMBER WAS OBTAINED AND TESTED. THE UNIT WAS RUN THROUGH THE FIVE DIFFERENT TESTS AND WAS FOUND TO FUNCTION AS INTENDED AS ALL TESTS PASSED. ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE IN QUALITY MANAGEMENT FOR APPROPRIATE TRACKING, TRENDING, AND FOLLOW-UP.

Additional Manufacturer Narrative

THIS FOLLOW-UP REPORT IS SUBMITTED TO FDA IN ACCORD WITH APPLICABLE REGULATIONS ¿ AND AS INDICATED BY TERUMO CARDIOVASCULAR SYSTEMS IN THE INITIAL REPORT SUBMITTED TO THE FDA ON DECEMBER 15, 2025. UPON FURTHER INVESTIGATION OF THE REPORTED EVENT, THE FOLLOWING INFORMATION IS NEW AND/OR CHANGED: D9 (DEVICE AVAILABILITY). G3 (DATE RECEIVED BY MANUFACTURER). G6 (INDICATION THAT THIS IS A FOLLOW-UP REPORT). H2 (FOLLOW-UP DUE TO ADDITIONAL INFORMATION). H3 (DEVICE EVALUATION ANTICIPATED BY MANUFACTURER - A SECOND FOLLOW-UP WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION AND/OR SUBMISSION OF NEW INFORMATION, THUS TCVS REFERENCES CONCLUSIONS CODE 11.) ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE IN QUALITY MANAGEMENT FOR APPROPRIATE TRACKING, TRENDING, AND FOLLOW-UP.

Additional Manufacturer Narrative

TERUMO HAS NOT RECEIVED THE DEVICE FOR EVALUATION; THEREFORE, THE INVESTIGATION HAS YET TO BE COMPLETED. TERUMO PLANS ON SUBMITTING A FOLLOW-UP REPORT WHEN THE INVESTIGATION IS COMPLETE AND WHEN MORE INFORMATION BECOMES AVAILABLE. FOR THIS REASON, TERUMO REFERENCES EVALUATION CONCLUSION CODE 11. THE PRODUCT BEING REPORTED DOES NOT HAVE A PRIMARY UNIQUE DEVICE IDENTIFICATION (UDI) NUMBER ASSOCIATED AS IT IS NON-STERILE AND IS INTENDED FOR FURTHER PROCESSING INTO CONVENIENCE KITS. NON-STERILE PRODUCTS ARE SUBSEQUENTLY STERILIZED ONCE INCORPORATED INTO A CONVENIENCE KIT. NON-STERILE PRODUCT IS AT NO TIME INTRODUCED INTO COMMERCIAL DISTRIBUTION.

Description of Event or Problem

THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING CARDIOPULMONARY BYPASS, A SMALL AMOUNT OF LEAKAGE WAS IDENTIFIED FROM THE SAFETY VALVE ON THE VENT LINE. SINCE THE LEAKAGE OCCURRED ON THE VENT LINE AND THE AMOUNT WAS SMALL, THE SAFETY VALVE WAS USED AS IS. NO CONSEQUENCE OR HEALTH IMPACT TO PATIENT. PRODUCT WAS NOT CHANGED OUT. PROCEDURE WAS COMPLETED SUCCESSFULLY.