The user facility reported to terumo cardiovascular systems that prior to cardiopulmonary bypass, during set up, there was no reading on the arterial temperature port.The issue was resolved by manually calculating the temperature.No known impact or consequence to patient.Product was not changed out.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 june 21, 2019.Upon further investigation of the reported event, the following information is new and/or changed: d4 (additional device information - added exp date).E1 (reporter name and address - last name).G4 (date received by manufacturer).G7 (indication that this is a follow-up report).H2 (follow-up due to correction and additional information).H3 (device evaluated by manufacturer).H4 (device manufacture date).H6 (identification of evaluation codes 11, 3331, 4114, 3259, 4307).Method code #1: 11 - testing of device from same lot/batch retained by manufacturer.Method code #2: 3331 - analysis of production records.Method code #3: 4114 - device not returned.Results code: 3259 - improper physical structure.Conclusions code: 4307 - cause traced to component failure.The affected sample was not returned for evaluation.A representative retention sample from the possible product/lot number combinations was tested and found to be functioning properly.An engineering investigation and capa have been initiated to determine a definitive root cause.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
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