The user facility reported to terumo cardiovascular that during cardiopulmonary bypass, the arterial temperature sensor did not measure properly and stopped working completely.As per the sales associate, when the perfusionist hooked the wire to the venous sensor it worked fine.As per the perfusionist, they could not exchange the temperature port because they were on bypass.They used the venous temperature for rewarming purposes.The part is not replaceable.The issue still continues with oxygenators.*no known impact or consequence to patient *product was not changed out *procedure 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 december 21, 2020.Upon further investigation of the reported event, the following information is new and/or changed: d4 (additional device information - added expiration date and lot number) d8 (device serviced by a third party) g3 (date received by manufacturer) g7 (indication that this is a follow-up report) h2 (follow-up due to additional information) h4 (device manufacture date) h6 (identification of evaluation codes 3120, 2199, 4582, 3005, 11, 3331, 4114, 3221, 4315) component code: 3120 - temperature sensor health effect - impact code: 2199 - no health consequences or impact health effect - clinical code: 4582 - no clinical signs, symptoms or conditions medical device problem code: 3005 - output problem 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 conclusion: 4315 - cause not established the affected sample was not returned so a thorough investigation could not be conducted.A representative retention sample was built into a water circuit with heated water flowing through the heat exchanger.Auxiliary thermometers were added immediately after the arterial outlet and immediately before the venous inlet.The difference between the auxiliary thermometers and the provided thermistors was negligible.Due to the device not being returned, the lack of information provided and the event not being duplicated with a retention sample, it is not possible to determine the exact cause this event.It is possible that the arterial thermistor was damaged in some way causing it to not read at all or correctly.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
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