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 apr 26, 2022.Upon further investigation of the reported event, the following information is new and/or changed: a2 (patient information - age, date of birth and gender); b7 (adverse event or product problem - other relevant history and medical conditions); d9 (device availability - added date returned to manufacturer); g3 (date received by manufacturer); g6 (indication that this is a follow-up report); h2 (follow-up due to additional information) ; h3 (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: d4 (additional device information - added expiration date).G3 (date received by manufacturer).G6 (indication that this is a follow-up report).H2 (follow-up due to additional information and device evaluation).H3 (device evaluated by manufacturer).H4 (device manufacture date).H6 (identification of evaluation codes 10, 11, 3331, 213, 67).Type of investigation #1: 10 - testing of actual/suspected device.Type of investigation #2: 11 - testing of device from same lot/batch retained by manufacturer.Type of investigation #3: 3331 - analysis of production records.Investigation finding: 213 - no device problem found.Investigation conclusions: 67 - no problem detected.The actual sample was visually inspected and found no break or other obvious anomaly that could lead to the decrease in the gas transfer performance.After having been rinsed and dried, it was tested for gas transfer performance in accordance with the factory's inspection protocol.The investigation result verified that the actual sample after rinsed, met the factory's control standard of gas transfer performance.In addition, no anomaly was observed in the manufacturing related records.As detailed information was not available, the cause of occurrence could not be clarified.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
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