SynCardia TAH-t Instructions for Use
SynCardia Systems, Inc.
Page 6
5.0 Precautions
1)
Measures should be taken to prevent infection or sepsis. Use strict aseptic
techniques during implantation.
2)
The outflow grafts must be pre-clotted before use.
3)
When closing the chest, a reduction in device output may indicate inflow
obstruction. Reposition the artificial ventricles by anchoring to a rib or moving
into the left plural space.
4)
Do not use an antifibinolitic agent like Aprotinine or Amicar with an active
clotting agent like FEIBA.
5)
Use only water-soluble antiseptic cleaners around the exit site. Ointments may
delay tissue in-growth into the driveline conduits.
6)
Each external console contains a primary and a backup controller. An
additional external console should also be available for use.
7)
A sudden reduction in SynCardia TAH-t flow may be due to a kink in the
pneumatic drivelines, or some inflow obstruction to the TAH-t, such as
tamponade. Defibrillation or CPR will not be effective.
8)
Flows should be kept at a reasonable output so that proper washing of the
ventricles is established.
