The user facility reported to terumo cardiovascular that prior to cardiopulmonary bypass, during prime, the customer has cut out one way valves from tubing packs.It leaked when tested.No known impact or consequence to the patient.It is unknown if the product was changed out.Procedure was completed successfully.
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The sample was not returned for evaluation, and the lot number was not provided; therefore, a complete investigation was not able to be conducted and the root cause could not be determined.All ops valves are subjected to a 100% leak test that undergoes 5 separate programs to test that each component in the valve is functioning properly.These units are also 100% visually inspected both during the leak testing step and during packaging.It is possible that damage occurred to the device at some point after manufacture, causing the part to leak during use.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
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