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 21, 2019.Upon further investigation of the reported event, the following information is new and/or changed: (device evaluation anticipated by manufacturer - a second follow-up will be submitted upon completion of the investigation and/or submission of new information, thus tcvs references conclusions code 11.) all available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
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This follow-up report is submitted to fda in accord with applicable regulations.Upon further investigation of the reported event, the following information is new and/or changed: (identification of evaluation codes 10, 11, 3331, 213, 67).Method code #1: 10 - testing of actual/suspected device.Method code #2: 11 - testing of device from same lot/batch retained by manufacturer.Method code #3: 3331 - analysis of production records.Results code: 213 - no device problem found.Conclusions code: 67 - no problem detected.The device was visually inspected upon receipt and it was found that the purge line tube and the sampling line tube had been cut off.The investigation result verified that the actual sample, after having been rinsed, was the normal product with no issue in the gas transfer performance, it is possible that the actual sample was used for the patient with large body surface area and the performance the fx15 size can serve was insufficient for the patient.From the available information and with no detailed information about the events leading up to the complaint or the absence of the involved perfusion record, the cause of the complaint cannot be determined.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
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