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 september 27, 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 11, 4114, 3331, 3221, 4315).Method code #1: 11 - testing of device from same lot/batch retained by manufacturer.Method code #2: 4114 - device not returned.Method code #3: 3331 - analysis of production records.Results code: 3221 - no findings available.Conclusions code: 4315 - cause not established.The affected sample was not returned for evaluation, therefore a thorough investigation could not be conducted.A representative retention sample was reviewed and confirmed that a venous thermistor was present and functioning.It's most likely that the venous thermistor was damaged during handling of the product, however, when or how the damage occurred is not able to be determined.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
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