OVERPRESSURE SAFETY VALVE

Additional Manufacturer Narrative

TERUMO WILL NOT RECEIVE THE DEVICE FOR EVALUATION; HOWEVER, 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, THEY NOTICED THAT THE VALVE WAS LEAKING; THE VALVE WAS CUT OUT AND REPLACED WITH ONE FROM THEIR SHELF SUPPLY. *NO CONSEQUENCE OR HEALTH IMPACT TO PATIENT *PRODUCT WAS CHANGED OUT *PROCEDURE WAS COMPLETED SUCCESSFULLY.

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 JANUARY 13, 2026. 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). H6 (IDENTIFICATION OF EVALUATION CODES 11, 3331, 4114, 3221, 4315). THE AFFECTED SAMPLE WAS NOT RETURNED FOR EVALUATION. 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. A RETENTION SAMPLE FROM THE SAME LOT NUMBER WAS OBTAINED AND MANUALLY RAN THROUGH THE FIVE TESTS, ALL TESTS PASSED WITH NO ANOMALIES NOTED. WITHOUT A RETURNED DEVICE, A THOROUGH INVESTIGATION COULD NOT BE PERFORMED, AND A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE IN QUALITY MANAGEMENT FOR APPROPRIATE TRACKING, TRENDING, AND FOLLOW-UP.