Abbott CentriMag User manual

CentriMag
™
Circulatory Support System
Clinical Reference Manual
READ ALL INDIVIDUAL CENTRIMAG SYSTEM COMPONENT INSTRUCTIONS FOR USE (IFU), THE CENTRIMAG CIRCULATORY
SUPPORT SYSTEM OPERATION MANUAL, AND THE ENTIRE CONTENTS OF THIS MANUAL BEFORE USING THE CENTRIMAG
CIRCULATORY SUPPORT SYSTEM.
Abbott Medical Clinical & Technical Support Phone number(s)
United States
Emergency HeartLine™
Support USA:
Tel: [phone]
Abbott Medical Main
Switchboard:
Tel: [phone]
Fax: [phone]
Manufacturer:
Thoratec Switzerland GmbH
Technoparkstrasse 1
CH-8005 Zürich
Switzerland
US Headquarters:
Abbott Medical
6035 Stoneridge Drive
Pleasanton, CA 94588
USA
www.abbott.com
PL-0318, Rev. 00
DCO No. 19-038
December 2019

3
™ Indicates a trademark of the Abbott group of companies.
‡ Indicates a third party trademark, which is property of its respective owner.
Pat. http://www.abbott.com/patents
© 2019 Abbott. All Rights Reserved.

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Contents
Introduction .................................................................................................................................................... 6
Indications for Use ............................................................................................................................................ 6
Contraindications ............................................................................................................................................. 6
Potential Adverse Events ....................................................................................................................................... 6
Warnings and Cautions ......................................................................................................................................... 6
Terminology and Abbreviations ............................................................................................................................... 7
Description...................................................................................................................................................... 7
Clinical Use of the CentriMag Circulatory Support System ........................................................................................ 8
General Principles ............................................................................................................................................................ 8
Types of Support ............................................................................................................................................................ 9
Preparing for CentriMag System Use ....................................................................................................................... 9
System Setup .................................................................................................................................................................. 9
Alternatives for Pump Priming and De-airing........................................................................................................................ 9
Priming Pack Technique .................................................................................................................................................. 9
Submersion Priming Technique ...................................................................................................................................... 10
Cannulas...................................................................................................................................................................... 12
Surgical Technique for Implantation ..................................................................................................................... 13
Overview ...................................................................................................................................................................... 13
Monitoring ................................................................................................................................................................... 13
Tunneling..................................................................................................................................................................... 13
CannulaSite Selection and Cannulation........................................................................................................................... 14
Intraoperative Device Management ....................................................................................................................... 15
Guidelines to Prevent Air Entrainment when Initiating Support ............................................................................................ 15
Patient Care and Management ............................................................................................................................ 15
Guidelines to Prevent Air Entrainment during Support ......................................................................................................... 16
CentriMag System Assessment and Adjustments ................................................................................................................. 16
Hemodynamic Assessment and Support ............................................................................................................................ 17
Intra-aortic Balloon Pump .............................................................................................................................................. 17
Defibrillation/Cardioversion............................................................................................................................................. 17
Anticoagulation............................................................................................................................................................. 18
Wound Care ................................................................................................................................................................... 18
Nutrition ..................................................................................................................................................................... 18
Physical Therapy ............................................................................................................................................................ 18
Patient Transport .......................................................................................................................................................... 18
Prevention and Management of Potential Complications...................................................................................................... 19
Alarms/Alerts and Troubleshooting ..................................................................................................................................... 20
Weaning and Explantation .................................................................................................................................. 20
Weaning Protocol ........................................................................................................................................................... 20
Pump Exchange ............................................................................................................................................................. 21
Explantation ................................................................................................................................................................. 21
Summary of Clinical Experience ........................................................................................................................... 21
Study Design ................................................................................................................................................................ 22
Accountability of the FTW Study Cohorts .......................................................................................................................... 24
Study Population Demographics and Baseline Parameters ................................................................................................... 25

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Safety and Effectiveness and Results ............................................................................................................................... 27
Device Malfunctions and Failures .................................................................................................................................... 30
Clinical Study Safety and Effectiveness Conclusions.......................................................................................................... 33

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Introduction
This manual is designed for healthcare professionals. It contains clinical and technical information for guidance in the proper and
safe use of the CentriMagTM Circulatory Support System when used as intended. The information in this manual supplements the
CentriMag Circulatory Support System Operation Manual and each of the individual system component instructions for use.
The CentriMag system performs life-sustaining functions. Users should have a practical knowledge of the principles of mechanical
circulatory support and should be aware of the physiological and psychological needs of a patient undergoing mechanical circulatory
support. New users should read this manual in its entirety before system operation. For experienced practitioners, this manual may
serve as a reference.
As with all prescription medical devices, clinical procedures should be conducted under the direction of the prescribing
physician. The professional staff at Abbott Medical regularly provide laboratory training and on-site, in-service programs. For
information, please contact your local Abbott Medical Clinical Field representative.
Indications for Use
The Indications for Use for the CentriMag Circulatory Support System include the following :
The CentriMag Circulatory Support System is indicated for use as part of a cardiopulmonary or other extracorporeal bypass circuit
for periods up to 6 hours [510k-cleared Device].
The CentriMag Circulatory Support System is indicated for temporary circulatory support for up to 30 days for one or both sides
of the heart to treat post-cardiotomy patients who fail to wean from cardiopulmonary bypass, providing a bridge to decision
when it is unclear whether the patient's heart will recover or whether the patient will need alternative, longer-term therapy [PMA
Approved Device].
The CentriMag Circulatory Support System is indicated for use as a right ventricular assist device [Humanitarian Device]. The
system, when used as a right ventricular assist device, is also authorized by Federal law to provide temporary circulatory support
for up to 30 days for patients in cardiogenic shock due to acute right ventricular failure. The effectiveness of this device for this
use has not been demonstrated.
Contraindications
The CentriMag Circulatory Support System is contraindicated for use as a cardiotomy suction device. The system is also contraindicated
for patients who are unable or unwilling to be treated with an appropriate anticoagulant such as Heparin or a comparable alternative.
Potential Adverse Events
Adverse events (e.g., complications) are a known risk of mechanical circulatory support use. The adverse events observed during four
clinical studies of the CentriMag system are listed below. The adverse events are listed in decreasing order of frequency, except for death,
because it is a non-reversible complication. There were no unexpected adverse events observed in these studies. For the incidence
summary of all the adverse events that were observed, refer to the Summary of Clinical Experience section.
Death
Bleeding
Respiratory Failure
Infection
Cardiac Arrhythmias
Renal Failure/Dysfunction
Right Heart Failure
Neurologic Dysfunction
Hemolysis
Hepatic Dysfunction
Hypotension
Venous Thromboembolism
Hypertension
Cardiac Tamponade
Psychiatric Episode
Pericardial Fluid Collection
Device Malfunction
Wound Dehiscence
Arterial Non-CNS Thromboembolism
Limb Ischemia
Myocardial Infarction
Aneurysm
Warnings and Cautions
Warnings are used if there is a potential for a serious hazard with misuse of the device, when special attention is required for safety of
the patient, or when special care should be exercised to prevent improper operation of the device that may cause damage.
Cautions are used to alert the user to exercise special care for the safe and effective use of the device.

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Terminology and Abbreviations
Abbreviations for terms used in this manual include:
ABP, arterial blood pressure
ACT, activated coagulation time
AMI, acute myocardial infarction
BiVAD, biventricular assist device
BUN, Blood Urea Nitrogen
CI, cardiac index
CPB, cardiopulmonary bypass
CVP, central venous pressure
ECMO, extracorporeal membrane oxygenation
FTW, Failure to wean
HIT, Heparin-induced thrombocytopenia
IABP, intra-aortic balloon pump
IJ, internal jugular
LAP, left atrial pressure
LPM, liters per minute
LVAD, left ventricular assist device
MAP, mean arterial pressure
mmHG, millimeters of Mercury
PADP, pulmonary artery diastolic pressure
PCCS, Post-cardiotomy cardiogenic shock
PCWP, pulmonary capillary wedge pressure
PFO, patent foramen ovale
PTT, partial thromboplastin time
PVR, pulmonary vascular resistance
RAP, right atrial pressure
RPM, revolutions per minute
RVAD, right ventricular assist device
TEE, transesophageal echocardiography
TEG, thromboelastography
Description
The CentriMag system is designed to provide a versatile and effective means for implementing mechanical circulatory support in a
variety of clinical scenarios. The system is intended to treat acute heart failure by decreasing ventricular workload, stabilizing
hemodynamic conditions, and facilitating potential myocardial recovery. Patients in acute cardiac failure are at risk of developing
multisystem organ failure which can threaten long-term survival. For these patients, the CentriMag system can provide short-term
circulatory support pending recovery of ventricular function or provide a means to hemodynamically stabilize the patient until an
alternative, longer-term therapy can be implemented.
The core components of the system include a CentriMag Blood Pump, 2nd Generation CentriMag Primary Console, motor, Mag Monitor,
flow probe, tubing, and cannulas.
Figure 1. CentriMag system
1. Cart
2. Monitor
3. Pump
4. Motor
5. Console
6. Backup motor
7. Backup console

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The primary design features of the system include:
Fully magnetically levitated impeller
No bearings, shafts, valves, or seals within pump
Low priming volume (31 cc) designed to reduce hemodilution
Disposable (polycarbonate) pump with standard 3/8” connectors
Reusable motor, console, non-invasive flow probe and accessories
Configurable as an LVAD, RVAD, or BiVAD
The CentriMag pump is a continuous flow, fully magnetically levitated centrifugal pump. When the pump is inserted into the motor
and activated, the internal impeller is electromagnetically levitated and centered. Large gaps between the impeller and pump housing
are designed to minimize potential shear forces on blood cells, allowing a high blood flow rate with minimal hemolysis and thrombosis.
Full MagLevTM technology suspends and rotates the impeller without a physical bearing.
The pump contains an inflow port on the top and an outflow port on the side that are at right angles to one another, as well as a
magnetically levitated impeller. When the impeller is rotated, a pressure gradient develops between the center and outside edge of the
pump, causing blood to flow from the inflow to the outflow port of the pump. The rotation of the impeller, as well as the resulting
blood flow, is not sensitive to the pump height or position. The amount of flow through the pump depends on the set speed of the
impeller, and the difference between the inlet and outlet pressures. Factors affecting the flow include the following:
Pump speed
Preload pressure
Afterload pressure
Inflow cannula size, resistance and position
Outflow cannula size, resistance and position
Tubing length
Figure 2. CentriMag pump
1. Inflow port
2. Impeller
3. Outflow port
Flow is generated by the rotation of the pump impeller. The blood flow is measured by a clamp-on, non-invasive flow probe and
displayed on the console screen and optional monitor.
The speed of the pump must be set high enough to overcome native cardiac pressure in order to prevent retrograde flow. Increasing the
RPM will increase the flow of blood through the pump.
CAUTION: If an increase in set speed does not cause an increase in flow, lower the set speed and assess the position of the
cannula and the patient's hemodynamic condition.
During patient support, the console is used to control pump speed, the resultant blood flow, and to monitor the safe operation of the
system. A cable connects the console to the motor, allowing flexibility in the pump motor and pump positioning. When needed, a battery
in the console will power the system for two hours. An additional console and motor should be available at all times for emergency backup.
For system specifications, refer to the CentriMag Circulatory Support System Operation Manual.
Clinical Use of the CentriMag Circulatory Support System
General Principles
The CentriMag system provides circulatory assistance for patients in acute hemodynamic compromise, a population whose treatments
options are limited.
WARNING: Read this entire manual before you use the CentriMag System. As with all prescription medical devices, clinical
procedures should be conducted under the direction of the prescribing physician. The physician must be trained on the use of the
System before using it. The professional staff at Abbott Medical regularly provide laboratory training and on-site, in-service
programs. For information, please contact your local Abbott Medical Clinical Field representative.
Temporary circulatory support with the system can restore hemodynamic stability, reduce the risk of further end-organ damage, and
provide conditions under which organ function can recover. By stabilizing the hemodynamics and optimizing the patient’s
condition, the
patient's end-organ function can be assessed to determine the clinical course for the patient. In many cases, myocardial and end-organ
recovery will be sufficient to allow weaning the patient from CentriMag system support. Some patients may need long-term support with
an implantable LVAD or a heart transplant.

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WARNING: The safety and effectiveness of use of the CentriMag system in an ECMO circuit (i.e. cardiopulmonary support > 6
hours) has not been demonstrated.
WARNING: The safety and effectiveness of use of the CentriMag system for use > 30 days has not been demonstrated.
Patients undergoing cardiac surgery who fail to be weaned from cardiopulmonary bypass due to poor cardiac function or high risk of
dysrhythmias may benefit from continued circulatory support with a ventricular assist device. In this post-cardiotomy scenario,
CentriMag system support can be initiated quickly without significant additional resources. Patients can then be transferred to a
recovery area or intensive care unit in a hemodynamically stable condition. Further patient assessment and treatment options can then
be considered.
Types of Support
The CentriMag system can be used as an LVAD, RVAD, or BiVAD as described in the sections below.
Isolated LVAD Support
When compromised or impaired left ventricular function results in a patient being unable to wean from cardiopulmonary bypass,
CentriMag LVAD support may be beneficial. Cannulation options include placement of a drainage cannula in the left atrium or left
ventricle with a return cannula placed or attached to the ascending aorta, axillary artery, or a femoral artery.
Isolated RVAD Support
Patients who may require isolated RVAD support include those in cardiogenic shock due to acute right ventricular failure1or those
whose right ventricular function is too compromised to wean from cardiopulmonary bypass. Patient history and pre-implant
assessment of the heart using cardiac echocardiography and a determination of PVR should help to identify patients who will benefit
from RVAD support for cardiogenic shock. Cannulation options are placement of a drainage cannula in the right atrium, right ventricle,
superior vena cava, or inferior vena cava, with a return cannula in the pulmonary artery.
RVAD Support following LVAD Implantation
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RVAD support may be required following implantation of a durable LVAD. Initiating LVAD support can cause an acute decrease in left
ventricular pressure that can change the position of the intra-ventricular septum, lead to distention of the right ventricle, and an
increase in right atrial pressure. Under these conditions, right atrial pressures above 15-20 mmHg are suggestive of right ventricular
dysfunction. Such a condition is often associated with a decrease in right ventricular contractility and tricuspid insufficiency. If
adequate LVAD flow cannot be achieved, and there are signs of right heart failure, it may be necessary to temporarily support the right
ventricle with a CentriMagTM RVAD. Diagnostic assessments include cardiac echocardiography, measurement of right heart pressures,
and if possible, direct visualization of right ventricular function.
Biventricular Support
Biventricular support may be necessary in instances where the entire heart is functioning too poorly to wean a patient from
cardiopulmonary bypass
.
Preparing for CentriMag System Use
The CentriMag system components and supplies are often stored in the operating room area to be immediately available when needed.
The consoles must be connected to AC power during storage to ensure that the batteries are always fully charged. A backup system must
always be close to the patient in the event it becomes
necessary to switch to backup system components.
System Setup
System setup and initiation of support is often performed under emergent conditions. The procedure for setting up the CentriMag system,
as described in the CentriMag Circulatory Support System Operation Manual, may be tailored to meet the anatomical and clinical
conditions of individual patients. Different methods for priming the pump and circuit are discussed below.
After the setup and priming steps are completed, all of the connections should be secured with bands.
CAUTION: Ensure that the tubing is secured with bands on a portion of the connection where the two components overlap ( i.e.
where the tubing covers the pump inlet). The tubing should be over the lip of the pump connector.
Alternatives for Pump Priming and De-airing
Priming should be performed using either a priming pack or circuit submersion technique that follows standard surgical protocols.
Two alternatives are described below.
Priming Pack Technique
Typical Contents
The following is a suggested list of equipment and supplies that may be used with a pre-assembled circuit or priming pack.3
1Humanitarian Use. The effectiveness of this device for this use has not been demonstrated.
2Humanitarian Use. The effectiveness of this device for this use has not been demonstrated.
3For the pumps, you will need one for univentricular support, two for biventricular support, plus a backup. For the console with motor and flow probe connected, you will need one of

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CentriMagTM pumps
Drainage cannulas
Return cannulas
2nd Generation CentriMagTM console with motor and flow probe connected
Preassembled circuit and priming pack
Two 3/8” two-sided, straight, barbed connectors (and backups), if not included with the cannula kits
Sterile tubing clamps and scissors
One liter of a warm balanced electrolyte solution for priming

Small nylon bands (~3” in length)
Typical Priming Pack Procedure
The priming pack procedure should be performed using aseptic techniques. To prime the pump:
1. Open the priming pack. Open the pump package. Attach the drainage tubing and return tubing to the appropriate barbed ports of
the pump. Suspend the recirculation bag from an IV pole.
CAUTION: The outside of pump packaging is not sterile.
2.
When possible, flush the recirculation bag and circuit with CO2 to remove air. Clamp the outlet lines from the reservoir bag. Fill
the reservoir bag with one liter of a balanced electrolyte solution. Open the reservoir bag air vent line.
CAUTION: Maintain an adequate level of priming solution in your reservoir bag at all times to prevent depriming the
circuit.
3. Raise the pump up to the level of the bag. Remove the clamps from the reservoir bag outlet lines. Slowly fill the circuit with
fluid by “walking” the fluid through the circuit, while venting the air through the vent line.
CAUTION: When the clamps are removed, ensure that you are priming the tubing slowly to minimize the risk of air entrainment.
4. Secure and lock the pump in the motor mount and recirculate the fluid at a low flow of approximately 1500 RPMs.
CAUTION: Ensure that the pump is properly seated, aligned, and locked into the motor.
Submersion Priming Technique
Typical Contents
The following is a suggested list of equipment and supplies that may be used for this technique.4
CentriMag pumps
Drainage cannulas
Return cannulas
2nd Generation CentriMag console with motor and flow probe connected

Standard 3/8”ID x 3/32” wall tubing
Two 3/8” straight barbed connectors per pump, if not included with the cannula kits
Sterile tubing clamps and scissors
Three liters of warm balanced electrolyte solution
Bulb syringe and scissors

Small nylon bands (~ 3” in length)
Submersion Technique – Dry Connection
The dry connection submersion technique should be performed using aseptic techniques. To prime the pump:
1. Fill a large sterile basin with three liters of a warm balanced electrolyte solution.
2. Open the pump package. Connect the inlet and outlet of the pump to separate segments of the tubing.
CAUTION: The outside of pump packaging is not sterile.
3. Slowly submerge the open side of the drainage tubing segment, then gradually submerge the entire piece, allowing the tubing to
fill completely from one end to the other, remaining under the surface at all times. Allow the pump to fill and deair. Continue
filling past the pump until the return tubing segment is also filled and deaired.
CAUTION: Avoid striking the pump housing in order to force air through the circuit, as damage to the pump housing may occur.
4. Once the circuit is completely primed and deaired, clamp both open ends of the tubing.
5. Pass the pump off the field (leave the ends of the tubing in the basin and maintain sterility of the tubing above the area which
was passed off) and place the pump in the motor.
6. Connect the flow probe to the return segment of the tubing.
each for univentricular support, two of each for biventricular support, plus one of each for backup.
4For the pumps, you will need two pumps for univentricular support and three pumps for biventricular support. For the console with motor and flow probe connected, you will need one of
each for univentricular support and two of each for biventricular support.

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7. Turn on the console, and set the speed to approximately 1500 RPMs with the clamps still on the drainage and return tubing in
the basin.
8. Remove the clamp from the drainage tubing and then remove the clamps from the return tubing. Allow the priming solution to
recirculate until all visible air is removed.
CAUTION: Ensure that the open ends of the tubing segments remain submerged during recirculation to avoid air
entrainment.
9. Inspect the circuit to ensure all air has been removed. If there is residual air, continue to run the pump with the open ends of
the tubing in the basin to complete the de-airing process.
CAUTION: If air is entrained in the pump head, turn the set speed to zero, and then walk the air bubble out of the pump.
10. Replace the clamps on the inflow and outflow tubing in the basin. The circuit is now ready for use.
Submersion Technique – Wet connection
The wet connection submersion technique should be performed using aseptic techniques. To prime the pump:
1. Fill a large sterile basin with three liters of a warm balanced electrolyte solution.
2. Slowly submerge one end of the drainage tubing segment, then gradually submerge the entire piece, allowing the tubing to fill
completely from one end to the other, remaining under the surface at all times. Clamp both ends of the tubing segment once all air
has been dispelled and tubing is primed. Repeat for the return tubing segment.
CAUTION: The CentriMag pump may magnetically attract to a metal basin. Use caution if a metal basin is used.
3. Open the pump package. Submerge the pump in the saline, rotating from side to side to ensure complete removal of air.
CAUTION: The outside of the pump packaging is not sterile.
4. Remove the clamp from one end of the drainage tubing segment and then connect it to the inflow of the pump. Remove the
clamp from one end of the return tubing segment and then connect it to the outflow of the pump. Ensure that all of the
connections are made while the components are fully submerged.
Figure 3. Submersion of tubing