The user facility reported to terumo cardiovascular that during cardiopulmonary bypass, they have noticed air bubble while on pump.Per user facility, they had been on pump for 15 minutes and the bubble detect, stopped the pump and air bubbles could been seen visually.They had to quickly recirculate and remove the air and go back on pump.No known impact or consequence to patient.Product was not changed out.Procedure was completed successfully.
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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 august 14, 2020.Upon further investigation of the reported event, the following information is new and/or changed: g4 (date received by manufacturer); g7 (indication that this is a follow-up report); h2 (follow-up due to additional information); h6 (identification of evaluation codes 4114, 3221, 4315).Method code: 4114 - device not returned; results code: 3221 - no findings available; conclusions code: 4315 - cause not established.The actual sample was not returned for evaluation.Without a sample and a provided lot number, a thorough investigation could not be performed and a root cause could not be determined.Review of manufacturing record and review of complaint records could not be performed since involved lot number was unknown.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
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