The user facility reported to terumo cardiovascular that prior to cardiopulmonary bypass, during prime, the device does not register an arterial temperature.Per user facility the temperature cable registers a temperature when used on the venous temp probe but not on the arterial.No known impact or consequence to patient; the product was not changed out; the procedure was completed successfully.
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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 october 18, 2019.Upon further investigation of the reported event, the following information is new and/or changed: d4 (additional device information - added exp date).G4 (date received by manufacturer).G7 (indication that this is a follow-up report).H2 (follow-up due to additional information).H4 (device manufacture date).H6 (identification of evaluation codes (4114, 11, 3331, 3259, 4307).Method code#1: 4114 - device not returned.Method code #2: 11 - testing of device from same lot/batch retained by manufacturer.Method code #3: 3331- analysis of production records.Results code: 3259 - improper physical structure.Conclusions code: 4307 - cause traced to component failure.There affected sample not was returned for evaluation so a thorough investigation could not be conducted.A representative retention sample from the same product/lot number combination was tested and found to be functioning properly.The root cause of the issue has been determined to be a high insertion force during assembly of the thermistor into the oxygenator module coupled with exposure to extreme temperature fluctuations.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
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