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 5, 2019.Upon further investigation of the reported event, the following information is new and/or changed: d4 (additional device information - added exp date).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 and device evaluation).H3 (device evaluated by manufacturer).H4 (device manufacture date).H6 (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 returned sample was visually inspected with no anomalies observed.The sample was built into a saline circuit and circulated at various speeds to observe the reported event.Bubbles were not observed under normal use of the pump.The returned sample was then leak tested by pressurizing to approximately 20psi and submerged in water and observed for bubbles.No bubbles were observed.A retention sample was obtained and also built into a saline circuit and circulated at various speeds to observe the reported event.Bubbles were not observed under normal use of the pump.The retention sample was then leak tested by pressurizing to approximately 20psi and submerged in water and observed for bubbles.No bubbles were observed.Upon evaluation of the returned sample, the pump was found to not form bubbles within the pump.As the reported event was not able to be replicated, a definitive root cause was not able to be determined.It's possible that the technique in the use of the pump was the cause for observing bubbles within the pump.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
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