|
Model Number LN130B |
Device Problem
Leak/Splash (1354)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 03/14/2017 |
Event Type
malfunction
|
Manufacturer Narrative
|
Terumo has received the device for evaluation; however, 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.The valve was cut out and a ¼ x ¼ connector was inserted in its place.*no known impact or consequence to patient, *product was changed out, *blood loss of 0.25cc or less, *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 31, 2017.Method - actual device evaluated; results - no failure detected; conclusions - use error caused or contributed to event.Visual inspection was performed on the returned sample, during which dried blood was noted within the valve.No other anomalies were noted anywhere on the device.A review of the device history record revealed no manufacturing anomalies.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 manually run through each of those tests.The sample passed all leak tests and met all specifications.It was communicated to terumo that the valve had been used in the aortic root vent line.During the investigation of a similarly reported event, simulation testing of the ops valve in an aortic root vent line found the ops valve to leak if the vent line was not properly clamped during cardioplegia delivery, and there was possible pressure buildup in the heart causing a positive pressure buildup in the vent line.The positive pressure relief valve then opened to release the pressure, and caused the ops valve to leak.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
|
|
Search Alerts/Recalls
|
|
|