This follow-up report is submitted to the fda in accord with applicable regulations - and as indicated by terumo cardiovascular system in the initial report submitted to the fda on october 28, 2016.(b)(4).The returned sample was visually inspected and it was found to not have the thermistor in the oxygenator port as it should.There was also no evidence of chemical presence in the empty port.A retention sample from 3cx*fx25rwc lot uh11 was visually inspected and confirmed to have a thermistor properly bonded within the oxygenator port.Review of the product's device history record found that the specific serial number of the returned sample had passed final visual inspection, confirming that the thermistor had been present in the port at the time of packaging.It is likely that the thermistor had been inserted into the port of the oxygenator, but never dipped into the chemical to bond it into the port, allowing it to come loose and not be present at the time of use.All available information has been placed on file in quality management for appropriate tracking, trending and follow up.
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