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 august 11, 2017.(b)(4).Visual inspection of the returned reservoir sample found clots present in the cardiotomy filter.The reservoir clotting test was performed on the reservoir sample, which included circulating bovine blood through the unit for one hour at a high flow rate.During visual inspection, it was found that no additional clots had formed within the filters of the reservoir, other than the dried clots from when the sample had been returned from the customer.Upon evaluation of the returned sample, it was confirmed that clots were present within the reservoir prior to decontamination.It was found to function as intended, without forming any additional clots or experiencing any flow anomalies.The reported event was unable to be replicated; therefore, a definitive root cause was not able to be determined.It is likely that patient conditions contributed to the formations of clots within the reservoir filter.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
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