The user facility reported to terumo cardiovascular that prior to cardiopulmonary bypass, during setup, they could not get temperature reading on arterial temperature port.No consequence/impact to the 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 may 3, 2019.Upon further investigation of the reported event, the following information is new and/or changed: 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 sample was not returned for evaluation.A full investigation is not possible.An engineering investigation and capa have been initiated to determine a definitive root cause.A retention sample from the same product/lot number combination was tested and found to be functioning properly.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
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