TERUMO CARDIOVASCULAR SYSTEMS CORPORATION VALVE, O.P.S BULK, N-S; OVERPRESSURE SAFETY VALVE
|
Back to Search Results |
|
Model Number LN130B |
Device Problem
Leak/Splash (1354)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 02/24/2021 |
Event Type
malfunction
|
Manufacturer Narrative
|
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.(b)(4).
|
|
Event Description
|
The user facility reported to terumo cardiovascular that during cardiopulmonary bypass, the one - way valve leaked.This issue has occurred 6 other times; however, specific dates and additional information is not known.There was a 50 cc of blood loss.The product was changed out.Procedure was completed successfully.
|
|
Manufacturer Narrative
|
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 march 19, 2021.Type of investigation #1: 11 - testing of device from same lot/batch retained by manufacturer.Type of investigation #2: 3331 - analysis of production records.Type of investigation #3: 4114 - device not returned.Investigation findings: 3221 - no findings available.Investigation conclusions: 4315 - cause not established.The affected sample was not returned for evaluation; therefore, a thorough investigation could not be conducted.The retention sample was visually inspected with no anomalies noted on the device.It was then manually run through the ops leak tests and passed.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.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
|
|
Search Alerts/Recalls
|
|
|