IMPELLA STOPPED
If the Impella Catheter has stopped suddenly:
1.
Try to restart the catheter at P-8.
2.
If the Impella does not restart at P-8, try to restart at P-2.
3.
If the Impella does not restart or stops again, wait 1 minute and
try to restart again.
4.
If the Impella restarts, wean down to P-2 as the patient can
tolerate. Under these circumstances, catheter function is not
reliable and the Impella may stop again.
5.
If the Impella does not restart, remove the Impella from the
ventricle as soon as possible to avoid aortic insufficiency.
SUCTION
Suction may occur if the blood volume available for the Impella Catheter
is inadequate or restricted. Suction limits the amount of support that the
Impella Catheter can provide to the patient and results in a decrease in
arterial pressure and cardiac output. It can damage blood cells, leading to
hemolysis. It may also be an indicator of right heart failure.
SUCTION WITH IMPELLA 2.5, IMPELLA CP, OR
IMPELLA CP WITH SMARTASSIST
If the Automated Impella Controller detects suction while running in
AUTO mode, it automatically reduces motor speed to lower the flow rate
to resolve the suction and displays the "Impella Flow Reduced" advisory
alarm. If the suction is cleared, the controller returns the flow rate to the
desired setting. If suction is still detected at the lowest motor speed, the
controller displays the "Suction" alarm.
If the Suction or Impella Flow Reduced alarm occurs during Impella
support, follow these recommended actions:
1.
Ensure patient has adequate volume.
2.
Reduce P-Level by one or two P-levels.
3.
Check the Impella Catheter for correct positioning using imaging.
Reposition the catheter by rotating or moving it into or out of the
ventricle slightly. Either or both of these actions could help move
the inlet of the Impella Catheter away from the interior ventricular
wall.
4.
Evaluate right ventricular function by assessing invasive
hemodynamics and/or echocardiography.
5.
Return P-level to pre-alarm setting.
If the Impella 2.5, Impella CP, or Impella CP with SmartAssist has
sudden low flows or suction at startup:
a) Remove the catheter from the patient and ensure that ACT is
250 seconds or above.
b) Closely inspect the inlet and outlet areas and remove any
thrombus or other foreign materials.
c) Replace catheter.
SUCTION WITH IMPELLA 5.0, IMPELLA 5.5 WITH
SMARTASSIST, OR IMPELLA LD CATHETER
If the Suction alarm occurs during support with the Impella 5.0 or
Impella LD Catheter, follow the recommended actions:
1.
Reduce P-level by 1 or 2 levels to reduce the effects of suction.
2.
Assess patient's fluid intake and output to confirm adequate
volume status.
3.
Check the Impella Catheter for correct positioning using imaging.
Reposition the catheter by rotating or moving it into or out of the
ventricle slightly. Either or both of these actions could help move
the inlet of the Impella Catheter away from the interior ventricular
wall.
4.
Confirm right ventricular function by assessing CVP or right side
function with echocardiography. If CVP is not an option, check the
pulmonary artery diastolic pressure to assess the patient volume
status.
5.
Return the P-level to pre-alarm setting.
Automated Impella Controller with SmartAssist
OPERATING THE IMPELLA CATHETER
WITHOUT HEPARIN IN THE PURGE
SOLUTION
The Impella Catheter is designed to be operated with a purge solution that
contains heparin. Operation of the system without heparin in the purge
solution has not been tested. In the event that a patient is intolerant to
heparin, due to heparin-induced thrombocytopenia (HIT) or bleeding,
physicians should use their clinical judgment to assess the risks versus
benefits of operating the Impella System without heparin.
If it is in the best interest of the patient to operate the system without
heparin, the dextrose solution is still required, and physicians should
consider systemic delivery of an alternative anticoagulant. The Impella
Catheter has not been tested with any alternative anticoagulants in the
purge solution. Use of alternative anticoagulants may reduce the longevity
or performance of the Impella catheter.
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