The user facility reported to terumo cardiovascular group that during cardiopulmonary bypass, there was not adequate membrane oxygenation with parameters that evidence to a low po2 in extracorporeal circulation with a flow rate between limit.Many changes in fio2, and arterial flow to support the low oxygenation.The location of the hospital has an atmospheric pressure of 560 mmhg and an altitude of 2640 meters over sea level.The perfusionist believes that the low oxygen delivery is due to the atmospheric pressure and high level city.No consequence or impact to the 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 may 9, 2022.Upon further investigation of the reported event, the following information is new and/or changed: d4 (additional device information - added exp date).G3 (date received by manufacturer).G6 (indication that this is a follow-up report).H2 (follow-up due to additional information).H4 (device manufacture date).H6 (identification of evaluation codes 3331, 4114, 3221, 4315).Type of investigation #1: 3331 - analysis of production records.Type of investigation #2: 4114 - device not returned.Investigation findings: 3221 - no findings available.Investigation conclusions: 4315 - cause not established.The actual sample was not returned and detailed information were not available.An investigation could not be performed and the cause of the occurrence could not be determined.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
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