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 june 16, 2021.Upon further investigation of the reported event, the following information is new and/or changed: g6 (indication that this is a follow-up report).H2 (follow-up due to additional information and device evaluation).H6 (identification of evaluation codes 10, 11, 3331, 4210, 4307).Type of investigation: #1: 10 - testing of actual/suspected device.Type of investigation #1: 11 - testing of device from same lot/batch retained by manufacturer.Type of investigation #3:3331 - analysis of production records.Investigation findings: 4210 - leakage/seal.Investigation conclusions: 4307 - cause traced to component failure.The affected sample was visually inspected, it was confirmed the presence of fluid in the back housing of the pump.No other visual concerns were found.The sample was then attached to a circuit, and filled with water and connected to a vacuum source, vacuum was applied to the returned device, after few seconds air bubbles from the back housing was seen between the seal rotor and stator.That confirmed the thin crack between the seal rotor and stator.Evaluating the device found that the leak occurred between the stator and the seal pad/rotor.A retention sample from the same product code/lot number combination was obtained.The sample was attached to a circuit, and filled with water and pressurized to 1000mmhg for approximately 15 minutes with no leakage observed.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
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