The user facility reported to terumo cardiovascular that during cardiopulmonary bypass, the pump adapter was causing decoupling event.The procedure performed was coronary artery bypass, as the surgical team was preparing to remove the partial occlusion clamp the patient became hypotensive.The low flow alarm was activated.Despite considerable efforts, the team was unable to adequately perfuse the patient for a period of approximately 10 minutes.The patient suffered an anoxic or hypoxic brain injury as a result.Additionally, a check of the pump head after the incident revealed low but audible grinding noise coming from the pump magnets.The motor was inspected by livanova and found to be in proper working order.The procedure was completed without apparent complication.The product was changed out.There was a blood loss of approximately 100 ml during 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 july 28, 2021.Upon further investigation of the reported event, the following information is new and/or changed: b5 (updated describe event or problem).D1 (updated suspect medical device).D4 (additional device information - updated model number, lot number and added expiration date).G3 (date received by manufacturer).G6 (indication that this is a follow-up report).H2 (follow-up due to correction and additional information).H4 (device manufacture date).H5 (updated labeled for single use).H6 (identification of evaluation codes 11, 3331, 4114, 3221, 4315).H8 (updated usage of device).Type of investigation #1: 11 - testing of device from same lot/batch retained by manufacturer.Type of investigation #2: 3331 - analysis of production records.Type of investigation #3: 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 and it is not possible to determine a cause of the reported event.A video was provided that showed the outlet of the pump was kinked, prohibiting flow from the pump.In this video, it can also be seen that the pump is spinning.The reported decoupling between the magnet and the vanes was not able to be thoroughly investigated as the pump was not returned.Pictures provided showed the pump adapter used was used over 14 months past it's expiration date.A representative retention sample from the same lot was setup to check flow rates at the outlet of the pump.The sample was tested at flow rates that span the pumps rated flow capability across the pumps rpm range.The pump outlet pressure was then measured at the respective flow and speed and the sample performed as expected.The retention sample was also subjected to pressure testing of 1000mmhg for approximately 15 minutes with no leakage observed.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
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