The user facility reported to terumo cardiovascular that prior to cardiopulmonary bypass, during setup, the arterial temperature probe ports were unable to record temperature. no known impact or consequence to patient.The product 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 march 11, 2019. upon further investigation of the reported event, the following information is new and/or changed: (additional device information - added exp date) (date received by manufacturer) (indication that this is a follow-up report) (follow-up due to additional information) (device evaluated by manufacturer) (device manufacture date) (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 the actual sample was not returned for evaluation.A retention sample from the same product/lot number 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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