CentriMag Blood Pump IFU (RVAS HDE)
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© 2015 Thoratec Switzerland GmbH – Document No. PL-0085, Rev. 09 (May 2015)
barriers. The package seals should be intact to
insure sterility. Do not use the Blood Pump, or any
of sterile accessory (cannulae, tubing or connector)
if the associated package is damaged. Contact
Thoratec regarding return of any damaged product.
2. The Blood Pump should be inspected prior to use
for any damage or particulate matter
contamination. Do not use the Blood Pump if
damaged or if any particulate matter is found on or
inside the Blood Pump. Contact Thoratec
regarding return of any suspect Blood Pump.
WARNINGS
1. Carefully read all Warnings, Precautions, Manuals,
and Instructions for Use for this and all related
Thoratec extracorporeal devices prior to use.
Failure to read and follow all instruction, or failure
to observe all stated warnings, could cause serious
injury or death to the patient.
2. Possible side effects include, but are not limited to:
Infection, mechanical failure, hemolysis, end organ
dysfunction, neurologic dysfunction, bleeding, and
embolic phenomena. These are potential side
effects with all mechanical circulatory support
systems.
3. The CentriMag RVAS is intended for use in
patients with a body surface area 1.4 m
2
or greater.
4. Ensure that the CentriMag Blood Pump and circuit
have been debubbled and primed properly prior to
use to minimize the risk of air entry to the patient.
5. Ingress of air into the pump that causes total
displacement of the fluid will result in depriming of
the Blood Pump and blood flow will stop. Clamp
the outlet tubing and stop the Blood Pump and
remove air prior to resuming circulation.
6. Do not expose the CentriMag Blood Pump to
chemical agents as they may affect the integrity of
this device. Anesthesia solutions such as forane
are known to degrade polycarbonate plastics.
7. To prevent backflow of the patient’s blood when
the Blood Pump outlet tubing is open, establish
and maintain a minimum pump speed that
overcomes line and patient resistance. Failure to
do this could allow retrograde flow and limit arterial
pressure. Retrograde flow may be diagnosed by
observing dashes (“---“) on the Primary Console
flow display.
8. A Blood Pump stoppage will create a reverse flow
shunt through the Blood Pump, as well as limit the
body’s ability to maintain adequate arterial
pressure. If the Blood Pump is stopped, clamp the
outlet tubing from the Blood Pump to prevent a low
flow, low pressure, and reverse flow condition. The
tubing clamp must be removed before returning to
normal pumping activity.
9. It is intended that systemic anticoagulation be
utilized while this device is in use. Anticoagulation
levels should be determined by the physician
based on risks and benefits to the patient.
10. The CentriMag Blood Pump is designed to be
operated only with the CentriMag drive console.
There are no safety or performance data known to
Thoratec which establishes compatibility of any
other manufacturer’s devices or components to the
CentriMag RVAS.
11. Potential risk to the patient should be evaluated
prior to changing a CentriMag Blood Pump.
12. Frequent patient and device monitoring is
recommended.
13. Do not use the CentriMag Blood Pump if the “Use
Before” Date on the package has past or expired.
14. Do not operate the CentriMag Blood Pump in the
absence of forward flow. The temperature within
the Blood Pump will rise and increased cellular
damage and clotting may result.
15. The CentriMag Blood Pump must be handled in an
aseptic manner until primed and connected to a
closed tubing circuit.
16. Do not operate the CentriMag Blood Pump with its
inlet tubing clamped as a negative pressure will be
generated in the Blood Pump and air bubbles may
formed in the priming fluid or blood.
17. Monitor patient’s hemodynamics and the Console
Flow display to insure adequate blood volume for
the inlet cannula position, Blood Pump RPM, and
desired flow. Increase Blood Pump RPM in small
increments to minimize the risk of exceeding the
available blood volume and causing inlet cannula
obstruction, suction, outgassing, and/or cavitation.
18. As with all continuous flow pumps, operating at too
high a speed can result in negative pressure at the
inlet which can lead to collapse of the ventricle or
blood vessels, inlet cannula obstruction, inspiration
of air, outgassing, cavitation and increased risk of
embolism. Transient negative pressure conditions
can be detected either by observing “line chatter”
on the inlet side of the pump, or with audio/visual
low flow alerts. Should “line chatter” or low flow
alerts occur, reduce pump speed until the negative
pressure condition resolves. Always operate the
system at the lowest speed consistent with the
volume of blood available to be pumped and
clinically acceptable circulatory support.
19. The CentriMag Blood Pump contains a magnet. To
avoid injury, keep all sharp metal objects and
instruments at least six inches away for the Blood
Pump. Do not remove the CentriMag Blood Pump
from its inner tray until ready to assemble RVAD
circuit and insert pump into the motor receptacle.
20. If CentriMag Blood Pump operation is ever halted
or flow reduced, consideration should be given to
monitoring and adjustment of the patient’s
anticoagulation status.
21. Do not restart the CentriMag Blood Pump if the
Blood Pump has been stopped for more than 5
minutes without adequate anticoagulation, as the
risk of thromboembolism is increased after blood
has remained stagnant in the Blood Pump,
extracorporeal circuit, connectors, and cannulae.
22. Monitor the pump and tubing for air because the
CentriMag Blood Pump, similar to other centrifugal
pumps, will pump air Immediately clamp Pump
outlet tubing if air enters the CentriMag Blood
Pump as gaseous emboli may be introduced into
the patient, with attendant risk of death or severe
