The user facility reported to terumo cardiovascular that during cardiopulmonary bypass, an fio2 of 100% and the po2 was only 150.No known consequence or impact to patient.Product was not changed out.Procedure completed successfully.Additionally, 91 minute to pump run, warm patient; sighed membrane.The act was normal and the flow was around 4.0 l/min blood flow.The patient did fine.
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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 january 09, 2023.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 affected sample was not returned for evaluation; therefore, a thorough investigation could not be performed.The manufacturing and incoming inspection records were reviewed with no anomalies found with three putative lot numbers.Past complaint file was found no similar report with the involve product code/lot number.Without the returned sample and detailed information of this case, 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.
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