TERUMO CARDIOVASCULAR SYSTEMS CORPORATION VALVE, O.P.S BULK, N-S; OVERPRESSURE SAFETY VALVE
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Model Number LN130B |
Device Problem
Leak/Splash (1354)
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Patient Problem
Hemorrhage/Bleeding (1888)
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Event Date 07/21/2023 |
Event Type
Injury
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Manufacturer Narrative
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Terumo has not received the device for evaluation; therefore, the investigation has yet to be completed.Terumo plans on submitting a follow-up report when the investigation is complete and when more information becomes available.For this reason, terumo references evaluation conclusion code 11.H6: component code: 3094 - one-way valve.Health effect - impact code: 4614 - serious injury / illness/ impairment.Health effect - clinical code: 1888 - hemorrhage / bleeding.Medical device problem code: 1354 - leak / splash.Investigation findings: 3233 - results pending completion of investigation.Investigation conclusions: 11 - conclusion not yet available.
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Event Description
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The user facility reported to terumo cardiovascular that during cardiopulmonary bypass, the one-way valve leaked.Per facility, the aortic root vent line 1-way valve popped and leaked approximately 200cc of blood before it could be clamped, and a new single sterile valve cut into the line to replace the leaky one.There was 200cc of blood loss.The product was changed out.The surgery was completed successfully.
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Manufacturer Narrative
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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, 4210, 4307) 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: 4210 - leakage/seal investigation conclusions: 4307 - cause traced to component failure the returned sample was visually inspected and noted that the negative umbrella valve was miss-seated; it was pushed into the center part of the negative and positive housing cavity.Ops valves are subject to a 100% leak test, which includes five different tests the units are run through to ensure there are no leaks and both the umbrellas and duckbills are functioning properly.The returned sample was setup to be manually run through each of these tests to determine if the umbrellas were functioning properly and not allowing air to enter the valve.As the negative umbrella was pushed in, all tests failed.A retention sample from the same product/lot number combination was obtained and visually inspected; no anomalies noted.Additionally, the retention sample was manually run through each of the above tests to determine if the umbrellas and duckbills were functioning properly, and the retention sample passed all the tests.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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Leaked one way valve.
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Manufacturer Narrative
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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 august 11, 2023.Upon further investigation of the reported event, the following information is new and/or changed: 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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Event Description
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Leaked one way valve.
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