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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 CentriMag

TM 

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. 

 
 

Содержание CentriMag

Страница 1: ...ENTRIMAG CIRCULATORY SUPPORT SYSTEM Abbott Medical Clinical Technical Support Phone number s United States Emergency HeartLine Support USA Tel 1 800 456 1477 Abbott Medical Main Switchboard Tel 1 925...

Страница 2: ...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...

Страница 3: ...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...

Страница 4: ...5 Safety and Effectiveness and Results 27 Device Malfunctions and Failures 30 Clinical Study Safety and Effectiveness Conclusions 33...

Страница 5: ...ce 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 b...

Страница 6: ...right ventricular assist device TEE transesophageal echocardiography TEG thromboelastography Description The CentriMag system is designed to provide a versatile and effective means for implementing me...

Страница 7: ...t 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 doe...

Страница 8: ...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 can...

Страница 9: ...plies 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 Tw...

Страница 10: ...echnique 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...

Страница 11: ...ailable venous and arterial cannula may be used at the preference of the clinician For central cannulation it is advisable to use cannulas that are wire reinforced to resist kinking The drainage cannu...

Страница 12: ...clamps are removed before the speed is set higher than 1000 RPMs there is a risk of retrograde flow NOTE If other manufacturers cannulas are used follow standard surgical techniques applicable to thos...

Страница 13: ...tions above for left and right sided support See options above for left and right sided support Two cannulation approaches are shown in the figures below The left ventricle is drained via the left ven...

Страница 14: ...E hemodynamic monitoring palpation and direct visualization of the heart will help to determine the volume of blood available for the circuit and the optimal level of flow After the chest is closed th...

Страница 15: ...econds allowing the patient s vascular system to adjust between each RPM change The pump set speed should be gradually increased to the desired flow If flow drops or tubing chatter is observed the set...

Страница 16: ...during insertion line chatter ramping of the flows or flow below the minimum alert Place a stopcock on the open ports of the central line to avoid air being entrained CAUTION Never leave any ports op...

Страница 17: ...Wound sites should be carefully inspected for signs of tissue breakdown or excessive drainage Undue pressure or torque to the surgical site should be avoided in order to minimize trauma with special c...

Страница 18: ...atient during transport Prior to shutting off the power supply and removal of the patient from the transport vehicle briefly unplug the console s power cord to confirm adequate battery charge and cons...

Страница 19: ...d a decreased dependence on inotropic support Initial assessments of ventricular function should be made without increasing inotropic support IABP support or without volume loading of the ventricles E...

Страница 20: ...5 The new tubing connectors are attached using a wet wet connection while taking care to eliminate air at the junction as well as in the circuit Secure these new connections with bands 6 Ensure that...

Страница 21: ...ents suffering from post cardiotomy cardiogenic shock who were unable to be separated from CPB prior to leaving the operating room Clinical Inclusion Criteria Enrollment in the studies was limited to...

Страница 22: ...pport Not applied to this study All possible measures have been attempted to correct low arterial pH arterial blood gas abnormalities electrolytes hypovolemia hypervolemia inadequate cardiac rate dysr...

Страница 23: ...entriMag system removal Adverse events and complications were recorded throughout the duration of CentriMag system support through device removal and until the patient was discharged from the hospital...

Страница 24: ...1 12 Patients N 32 26 12 25 Sex Male 24 75 15 58 8 67 20 80 Female 8 25 11 42 4 33 5 20 Race White 24 75 4 13 4 13 N A13 N A13 19 76 4 16 2 8 African American Other Age mean years SD 58 13 8 59 11 6 5...

Страница 25: ...seline Laboratory Values FTW from CPB G030052 S21 Variable N Mean SD Median Min Max Blood Urea Nitrogen mg dl 32 39 1 21 3 32 12 94 Creatinine mg dl 32 1 8 0 8 1 6 0 9 4 Total Bilirubin mg dl 31 1 8 1...

Страница 26: ...ut not identical across the studies so direct comparisons are not possible However the table shows that general trends in types and incidence of adverse events were similar across all four studies Tab...

Страница 27: ...otension 1 1 3 5 5 19 2 2 17 0 0 0 8 8 8 Hepatic Dysfunction 1 1 3 8 7 27 3 2 17 0 0 0 12 10 11 Renal Failure Dysfunction 8 8 25 3 3 12 1 1 8 12 12 48 24 24 25 Neurologic Dysfunction 0 0 0 8 8 31 2 2...

Страница 28: ...4 4 Other 1219 9 28 0 0 0 0 0 0 2120 10 40 33 19 20 19 Right arm compartment syndrome bronchorrhea and desaturation cardiogenic shock with suspected platelet dysfunction tear in ventricular tissue nea...

Страница 29: ...valuate the safety of the device These data were obtained by analyzing adverse events associated with marketed CentriMag systems which were reported to Abbott Medical between June 1 2014 and June 30 2...

Страница 30: ...he tables below Table 15 CentriMag Effectiveness in FTW Subjects from CPB Pivotal Study G030052 S21 Survival and Primary Endpoint Clinical Study N Survival to 30 Days Post device Survival To Discharge...

Страница 31: ...y Endpoint Clinical Study N Survival to 30 Days Post device Survival to Discharge Primary Endpoint Success Cardiogenic Shock Trial G030052 22 26 11 26 42 Not Defined RVAS Trial G040029 23 12 7 12 58 N...

Страница 32: ...ing acute myocardial infarction or post cardiotomy failure to wean from cardiopulmonary bypass and in patients with acute right ventricular failure from any cause In all studies the adverse event rate...

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