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 code: results pending completion of evaluation.Conclusions code: conclusion not yet available-evaluation in progress.
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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 7, 2018.(b)(4).The sample was not returned for evaluation nor were any pictures provided, therefore a thorough investigation could not be performed and definitive root cause can not be determined for this event.The most likely root cause is that the buffer solution was not completely wiped off the product after buffer fill during manufacturing.This is not a functional issue.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
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