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.(b)(4).Results pending completion of evaluation.Conclusions: conclusion not yet available-evaluation in progress.
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This follow-up report is submitted to fda in accord with applicable regulations.(b)(4).The sample for this complaint was not returned for evaluation.The sample for the complaint that occurred at the same time was returned and evaluated.The returned unit was visually inspected upon receipt, it confirmed the reported observation.The returned unit was cut open and the particulate/ foreign matter was carefully taken out.It was then placed on the ftir instrument and substance spectrum was obtained.The output closely match to polyaniline (pani).It was determined that the substance is not native to tcvs facility and the supplier was notified about the issue.A retention sample was obtained from same product code / lot number, no anomalies noted including any foreign matter.All ports of the arterial filters are capped to keep the contaminants out.The actual root cause of the particulate found within the arterial filter can not be determined.It is likely that the foreign matter may have transferred to the product during handling or contaminated prime solution being used; however, it was not able to be confirmed.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
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