The user facility reported to terumo cardiovascular systems corporation that there was a difference in temperature readings from the aps1 oxygenator and the shunt sensor.The shunt sensor was lower by 3 degrees.It is unknown as to when the problem occurred, if there was any delay in the procedure or if the product was changed out; however, the surgery was completed successfully.
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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.There were two samples returned for evaluation.Both samples were visually inspected, during which no anomalies were noted.A control sample from lot tf25k was obtained in order to compare the temperatures read.The first sample was set up in a circuit, as the venous line, with the control unit (arterial) and buffer solution was circulated through both samples.The cdi 500 was used in order to read the temperatures from each shunt sensor.Once the temperatures for each shunt sensor were settled, there was a temperature difference of approximately.2 degrees celsius.During the testing of the second sample, the temperature was different by.1 degrees.A review of the device history record revealed no manufacturing anomalies.A definitive root cause could not be identified; therefore, this complaint is not confirmed.All available information has been placed on file in quality management for appropriate tracking, trending and follow up.
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