Introduction; Indications For Use; Contraindications; Potential Adverse Events - Abbott CentriMag Reference Manual

Introduction

This manual is designed for healthcare professionals. It contains clinical and technical information for guidance in the proper and
TM Circulatory Support System when used as intended. The information in this manual supplements the
safe use of the CentriMag
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
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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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