Model Number 3CX*FX15RE30C |
Device Problem
Break (1069)
|
Patient Problem
No Information (3190)
|
Event Date 08/24/2020 |
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 there was a broken inlet line on the entrance to the oxygenator.Additionally, the perfusionist identified that this occurred because the box created pressure of the paper barrier in the package directly on this line.It is unknown when this event occurred, whether the product was changed out, or if there was any effect on the patient or results of the surgery.Terumo continues to attempt to gain more information regarding this event from the user facility.
|
|
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 september 11, 2020.G4 (date received by manufacturer).G7 (indication that this is a follow-up report).Additional information was received from the subsidiary regarding this event.It was determined that this event is not a malfunction of the actual device.The reported event was due to the repacking of the device at the subsidiary.There will be no additional follow ups submitted regarding this event.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
|
|
Search Alerts/Recalls
|