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 december 9, 2020. upon further investigation of the reported event, the following information is new and/or changed: d4 (additional device information - added lot number); d10 (device availability - added date returned to manufacturer); g4 (date received by manufacturer); g7 (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 exp date).D8 (added device serviced by a third party).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 4739, 2199, 4582, 1354, 10, 3331, 213, 67).Components code: 4739 - gas exchanger.Health effect - impact code: 2199 - no health consequences or impact.Health effect - clinical code: 4582 - no clinical signs, symptoms or conditions.Medical device problem code: 1354 - leak/splash.Type of investigation #1: 10 - testing of actual/suspected device.Type of investigation #2: 3331 - analysis of production records.Investigation findings: 213 - no device problem found.Investigation conclusions: 67 - no problem detected.The actual sample was visually inspected upon receipt with no anomalies including a damage which could have been a trigger of the generation of leakage.The blood channel of the actual ample was filled with saline solution and a pressure of 2kgf/cm2 was applied for 6 hours with no leakage observed.Afterwards, the water channel of the actual sample was filled with water and a pressure of 3kgf/cm2 was applied for 6 hours and no leakage was observed.Based on the investigation result, it was confirmed that there were no anomalies on the actual sample was found which could have been a trigger of the generation of leakage.All available information has been placed on file in quality management for appropriate tracking, trending and follow-up.
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