Model Number 3CX*FX25REC |
Device Problem
Break (1069)
|
Patient Problem
No Patient Involvement (2645)
|
Event Date 10/13/2016 |
Event Type
malfunction
|
Manufacturer Narrative
|
Terumo has not received the actual 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 more information becomes available.(b)(4).
|
|
Event Description
|
The company representative reported to terumo cardiovascular systems that prior to cardiopulmonary bypass, during setup, the manifold on the oxygenator was broken when opened.No patient involvement as this occurred during setup.Product was change out.Surgery was completed successfully.
|
|
Manufacturer Narrative
|
The sample was not returned for evaluation.A review of the device history record revealed no manufacturing anomalies.A retention sample from the same product code/lot number combination was visually inspected and confirmed to not have any damages or anomalies, specifically with the manifold.A definitive root cause could not be determined; therefore, this complaint is not confirmed.All available information has been placed on file in quality management for appropriate tracking, trending and follow up.
|
|
Manufacturer Narrative
|
This follow-up report is submitted to the fda in accord with applicable regulations - and as indicated by terumo cardiovascular system in the initial report submitted.(b)(4).The sample was returned on december 12, 2016, after the final medwatch was sent on november 18, 2016.Visual inspection was performed on the returned sample.It was confirmed that two of the three stopcocks on the sampling manifold were damaged.One of the yellow non-vented caps was broken and shattered, and the port of the other stopcock was broken off along with the yellow non-vented cap being shattered off of the port.A retention sample from the same product code/lot number combination was visually inspected and confirmed to not have any damages or anomalies, specifically with the manifold.It is likely that the manifold had been damaged during shipping and handling by an external force; however, when or how this force was applied to the sampling manifold could not be determined.All available information has been placed on file in quality management for appropriate tracking, trending and follow up.
|
|
Search Alerts/Recalls
|