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 18, 2020.Upon further investigation of the reported event, the following information is new and/or changed: h6 (identification of evaluation codes 510, 2645, 4582, 1354, 11, 3331, 4114, 3221, 4315) component code: 510 - sensor.Health effect - impact code: 2645 - no patient involvement.Health effect - clinical code: 4582 - no clinical signs, symptoms or conditions.Medical device problem code: 1354 - leak/splash.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 sample was not returned for evaluation; therefore, a thorough investigation could not be performed.The reported unit / lot number was used almost a year past its expiration date.Date of use; november 24, 2020.Date of expire; november 30, 2019.The retention sample from the same lot number was previously inspected for another complaint ((b)(4)) and confirmed to have no traces of buffer on the outside of the unit or inside the pouch.The retention sample was then pressurized with air up to 1030 mmhg, submerged in a water bath, and observed for any leaks.No leaks were noted on the retention sample.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
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