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 september 14, 2018.(b)(4).A circuit was set up and a temperature probe was hooked up to the oxygenator's thermistor.No reading was procured.The probe was connected to the thermistor attached to the retained reservoir, and a reading was obtained.This confirms that the thermistor is defective.The most likely root cause for the thermistor not giving any readings is that the thermistor is damaged internally.The internal electronic circuitry was damaged, most likely due to excessive shock force on the thermistor, post manufacturing.How or when this force was applied was not able to be determined.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
|