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10 

 

 

CentriMag

TM

 pumps 

 

Drainage cannulas 

 

Return cannulas 

 

2

nd

 Generation CentriMag

TM 

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 CO

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 

 

2

nd 

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. 

4

 

For 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.

 

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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