TERUMO CARDIOVASCULAR SYSTEMS CORPORATION VALVE, O.P.S BULK, N-S; OVERPRESSURE SAFETY VALVE
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Model Number LN130B |
Device Problem
Infusion or Flow Problem (2964)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Type
malfunction
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Manufacturer Narrative
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The sample was not returned for evaluation; therefore, the complaint was not confirmed and a root cause was not able to be determined.From the complaint description, the issue seems to be with the lack of slit in the duckbill valve, which would then not allow flow through the valve during use.During assembly of ops valves, all duckbill valves are to be squeezed and confirmed to open prior to placing them into the housing.Ops valves are also 100% leak tested in process, during which a flow test is performed to confirm the duckbill opens and allows flow in the correct direction.This issue is currently undergoing an investigation; however, it is presently believed that the lack of flow through the duckbill valve is due to a process change in the water that the duckbills are washed in at the supplier.(b)(4).All available information has been placed on file in quality management for appropriate tracking, trending and follow-up.
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Event Description
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The user facility reported to terumo cardiovascular that prior to cardiopulmonary bypass, during setup, the ops valves in the tubing pack would not open.*no consequences or impact to patient, *product was not changed out.*procedure was completed successfully.
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Manufacturer Narrative
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(b)(4).The investigation results and conclusions, previously reported, remain the same.
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Event Description
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(b)(4).
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Search Alerts/Recalls
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