The user facility reported to terumo cardiovascular that prior to cardiopulmonary bypass, during prime, the venous temperature probe broke off from the oxygenator.*no known consequnce or impact to patient.*product was not changed out.*procedure was completed successfully.
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Terumo has not received the device for evaluation; therefore, the investigation has yet to be completed.Terumo plans on submitting a follow-up report when the investigation is complete and when more information becomes available.For this reason, terumo references evaluation conclusion code 11.Component code: 918- probe 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: 1069 - break.Investigation findings: 3233 - results pending completion of investigation.Investigation conclusions: 11 - conclusion not yet available.
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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 november 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 11, 3331, 4114, 3259, 4307) 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: 3259- improper physical structure investigation conclusions: 4307 - cause traced to component failure the affected sample was not returned; however, a photo was provided that confirmed the venous temp probe was broken.A representative retention sample was inspected for damage with no damage noted on the device.All capiox units are 100% visually inspected at several points in the production and packaging processes.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
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