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.(b)(4).Results: results pending completion of evaluation.Conclusions: conclusion not yet available-evaluation in progress.
|
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 20, 2017.The sample was not returned for evaluation.A retention sample from the same affected part and lot number was obtained and visually inspected, no anomalies were found.The retention sample was connected to a closed loop saline circuit and ran for 30 minutes at different rpms - 600, 900 and 1200.No issues were noted during the test.Since the affected device was not returned for evaluation a thorough investigation could not be performed and an actual root cause can not be determined.A possible root cause would be, the pump was not seated properly over the drive motor receptacle; however, this was not able to be confirmed.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
|