Medtronic BBAP40 Addendum

Supplement: Temporary modification to indications for use for

System Part

Device

Description

FDA-Cleared Indications for Use

560BCS1

Bio-Console

TM

560

The Medtronic centrifugal blood pumping system is

extracorporeal support devices

560BCS1, ACM100, ACM200, ACM300, BD38, BD14
560A, HC150A, 95184-001, 95185-001, AP40AST
AP40, CBAP40, BBAP40
95244, 95134, CB2980POLY, CB4627, DP38T, DP38PT

Background

On April 6, 2020 the United States Food and Drug Administration (FDA) published the following
guidance: “Enforcement Policy for Extracorporeal Membrane Oxygenation and Cardiopulmonary Bypass

Devices during the Coronavirus Disease 2019 (COVID-19) Pubic Health Emergency.”

Under this guidance, the FDA is allowing temporary limited modifications to the indications of certain
FDA-cleared or FDA-approved cardiopulmonary devices without prior submission of premarket
notification. These modifications are allowed, in light of the public health emergency, when they do not
create an undue risk. This indication modification is in effect for the duration of the public health
emergency related to COVID-19, as declared by the Department of Health and Human Services (HHS).

Indications for use

In accordance with the FDA guidance, the devices listed below have a modified indication for use during
the COVID-19 public health emergency. This indication modification has not been cleared or approved
by the FDA, but shall apply temporarily to the device models listed in this supplement:

The device can be used for longer than 6 hours in an extracorporeal membrane oxygenation (ECMO)
circuit to treat patients who are experiencing acute respiratory or acute cardiopulmonary failure.

The table below shows the system part numbers, device descriptions, and FDA-cleared indications for
use for the various cardiopulmonary devices granted the above modified indication.

Numbers*

ACM100
ACM200
ACM300
BD38
BD14

Extracorporeal
Blood Pumping
Console with
accessories:

 Autoclamp
 Bubble detector

(adult)

intended to pump blood through the extracorporeal
bypass circuit for extracorporeal support for periods
appropriate to cardiopulmonary bypass procedures (up
to 6 hours).

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System Part

Numbers*

Device

Description

FDA-Cleared Indications for Use



560A

External

Drive

The Medtronic external drive motor 560A is indicated for

HC150A

Emergency Hand

Refer to the Affinity CP centrifugal blood pump IFU for

95184

-

001

TX50 Adult Flow

The

Bio-Probe™ blood flow monitoring system is to be

AP40AST

Affinity CP Adapter

Refer to the Affinity

CP centrifugal blood pump IFU for

AP40

Affinity CP

The Affinity CP centrifugal blood pump is used to pump

CBAP40

Affinity CP

The Affinity CP centrifugal blood pump with Cortiva

Bubble detector
(pediatric)

95185-001

Motor for Affinity

TM

CP Centrifugal
Blood Pump

Crank for Affinity CP
Centrifugal Blood
Pump

Transducer

TX50P Pediatric
Flow Transducer

Centrifugal Blood
Pump**

use with the Affinity CP centrifugal blood pump.

indications for use.

used with an appropriate model Bio-Console
extracorporeal blood pumping console to measure
directly the blood flow in the extracorporeal perfusion
circuit.

indications for use.

blood through the extracorporeal bypass circuit for
extracorporeal circulatory support for periods
appropriate to cardiopulmonary bypass (up to 6 hours).

It is also indicated for use in extracorporeal support
systems (for periods up to 6 hours) not requiring
complete cardiopulmonary bypass (for example,
valvuloplasty, circulatory support during mitral valve
reoperation, surgery of the vena cava or aorta, liver
transplants).

Centrifugal Blood
Pump with
CortivaTMBioActive
Surface**

The Affinity CP centrifugal blood pump is driven by the
external drive motor or the emergency handcrank.

The Affinity CP centrifugal blood pump is intended for
use with pump speed controllers approved by Medtronic
or may be used with the StöckertTMand Sorin
centrifugal pump systems or the SarnsTMand Terumo

TM

TM

centrifugal systems by attaching the Affinity CP adapter.

bioactive surface is used to pump blood through the
extracorporeal bypass circuit for extracorporeal
circulatory support for periods appropriate to
cardiopulmonary bypass (up to 6 hours).

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System Part

Numbers*

Device

Description

FDA-Cleared Indications for Use

It is

also indicated for use in extracorporeal support

BBAP40

Affinity CP

The Affinity CP centrifugal blood pump with Balance

95244

Adult Bio

-

Probe

Refer to the Bio

-

Probe blood flow monitoring system

systems (for periods up to 6 hours) not requiring
complete cardiopulmonary bypass (for example,
valvuloplasty, circulatory support during mitral valve
reoperation, surgery of the vena cava or aorta, liver
transplants).

The Affinity CP centrifugal blood pump with Cortiva
bioactive surface is driven by the external drive motor or
the emergency handcrank.

The Affinity CP centrifugal blood pump with Cortiva
bioactive surface is intended for use with pump speed
controllers approved by Medtronic or may be used with
the Stöckert and Sorin centrifugal pump systems or the
Sarns and Terumo centrifugal systems by attaching the
Affinity CP adapter.

Centrifugal Blood
Pump with
Balance

TM

Biosurface1**

biosurface is used to pump blood through the
extracorporeal bypass circuit for extracorporeal
circulatory support for periods appropriate to
cardiopulmonary bypass (up to 6 hours).

It is also indicated for use in extracorporeal support
systems (for periods up to 6 hours) not requiring
complete cardiopulmonary bypass (for example,
valvuloplasty, circulatory support during mitral valve
reoperation, surgery of the vena cava or aorta, liver
transplants).

The Affinity CP centrifugal blood pump with Balance
biosurface is driven by the external drive motor or the
emergency handcrank.

The Affinity CP centrifugal blood pump with Balance
biosurface is intended for use with pump speed
controllers approved by Medtronic or may be used with
the Stöckert and Sorin centrifugal pump systems or the
Sarns and Terumo centrifugal systems by attaching the
Affinity CP adapter.

1

Technology licensed under agreement from BioInteractions, Limited, United

Kingdom.

Flow Probe, 3/8”**

95134

Pediatric Bio-Probe
Flow Probe, 1/4”**

operator manual for indications for use.

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System Part

Numbers*

Device

Description

FDA-Cleared Indications for Use

CB2980POLY

CB4627

DP38T

DP38PT

*Other part numbers that include these devices in other configurations are also covered.

** Also available in tubing packs
*** Only available in tubing packs

Adult Bio-Pump
Flow Probe, 3/8”
with Cortiva
BioActive Surface**

Pediatric Bio-Probe
Flow Probe, 1/4”
with Cortiva
BioActive Surface**

Adult Bio-Pump
Flow Probe, 3/8”
with Trillium
Biosurface***

Pediatric Bio-Pump
Flow Probe, 1/4”
with Trillium
Biosurface***

Device performance

There are no changes to device performance as described in the instructions for use for these devices.

Durability testing

The following testing and documentation showed no failures:

Medtronic in vitro test, applicable to AP40, BBAP40, CBAP40, 560A, AP40AST



Medtronic in vivo test, applicable to CBAP40, 560BCS1, 95184-001, 95244



Medtronic’s strategic partner’s documentation, applicable to BBAP40, 560A



Medtronic reliability and cycling testing, applicable to BD38, BD14, ACM100, ACM200, ACM300



AP40, BBAP40, CBAP40, 560A

Medtronic conducted extended duration testing on the AP40 pump with 560A external drive motor.
Design verification testing for the AP40, BBAP40, and CBAP40 showed one known failure mode related
to the upper pivot bearing. This failure mode can be mitigated by the following:

Continuously monitor flow proximal to the pump inlet to ensure no line kinks or air



entrainment.
Ensure appropriate anticoagulation levels to reduce clotting.



Reduce the revolutions per minute (RPM) to limit thrust force and wear on the upper bearing.



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Ensure the pump is properly oriented with the outlet port at the highest point and parallel to



the ground.

Warning: Ensure that the pump is fully primed before priming the circuit and before operating. A fully
primed pump ensures proper lubrication of the bearing system. Operating the pump dry or with
constrained air in the bearing system will cause bearing damage, which could result in patient injury,
illness, or death.

Warning: Never operate extracorporeal support devices unattended. The pump may stop, resulting in
no forward flow, which could result in patient injury, illness, or death. Retrograde flow is possible in this
event, so an arterial line clamp is recommended.

BBAP40, 560A

Medtronic’s strategic partner performed bench studies which simulated BBAP40 with 560A external
drive motor use for a duration of 14 days. These studies included a bench durability study at 37°C
(98.6°F) in blood analog to assure mechanical stability, with a substantial margin of safety. The device
was oriented with the outlet port at the highest point and parallel to the ground and met all critical flow
performance attributes after this study, including pressure-flow performance and product integrity. All
testing passed and there were no failures. All completed testing was done in accordance with the
international standard ISO 18242:2016, Cardiovascular implants and extracorporeal systems —

Centrifugal blood pumps.

Summary of animal and clinical performance

AP40, BBAP40, CBAP40

Clinical data from the Extracorporeal Life Support Organization (ELSO) registry shows that between
January 1, 2018 and July 19, 2019, the AP40, BBAP40, and CBAP40 were used in 299 adult and 56
pediatric ECMO procedures. Total reported complication rates were 3.0% for adult patients and 5.4% for
pediatric patients. The reported mechanical complications were 2.3% for adult patients and 3.6% for
pediatric patients. The reported hemolysis complication (adult: 0.7%; pediatric: 1.8%) is a known
adverse effect associated with the use of the product, as specified in the Instructions for Use.

Medtronic’s strategic partner conducted an in vivo study in an ovine model for 4 days to confirm and
simulate clinical functionality of the blood pump for the intended duration of uses. Anticoagulation in
the in vivo model reflects continuous heparin drip administration, which is typical of extracorporeal life
support platforms (ACT 180-220s). High (5 L/min) and low (2 L/min) blood flow rates were sustained for
96 hours with no clots in any device location, and blood pump functionality was confirmed.

Biocompatibility testing of the blood contacting materials used in the AP40 series pumps was originally
conducted to support use of the device for limited durations (use of less than 24 hours). Medtronic’s
strategic partner also completed testing for expansion to prolonged use of the BBAP40, which includes
the addition of subacute toxicity and implantation. Design, sterilization, and packaging specifications
remain unchanged from the currently marketed devices. The results of the biocompatibility testing
clearly demonstrate that the BBAP40 meets ISO 10993-1 as recommended by FDA guidance document
“Use of International Standard ISO 10993-1, ‘Biological evaluation of medical devices – Part 1: Evaluation
and testing within a risk management process.’”

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95244, 95134, CB2980POLY, CB4627, DP38T, DP38PT

A review of the Bio-Probe Blood Flow Monitoring System was conducted to assess existing
biocompatibility data and document any gaps in the overall biocompatibility evaluation, based on the
EN ISO 10993-1:2009 standard. Results of the review found that the existing data is sufficient to meet
the requirements of the standard for a limited duration of use (24 hours or less). Additional testing to
support prolonged use (24 hours to 30 days) has not been performed on these devices. An evaluation of
post-market surveillance data confirms that no field complaints or vigilance reporting exists to suggest
toxicity related to prolonged use of these devices.

560BCS1

Published evidence from 2017 outlined the use of ECMO for respiratory support during critical airway
surgery. Between April 2012 and March 2015, 9 patients underwent ECMO-supported airway operations
for conditions such as tracheal stenosis and tracheal tumors. In some patients (the exact number was
not provided), a Medtronic Bio-Console 560 was used. The authors noted no technical difficulties related
to the use of the Bio-Console 560 and no ECMO-related complications. The time on ECMO ranged from

1.431hours to 216 hours, with a median time of 2.42 hours. The authors noted that ECMO can be
considered a feasible and safe method for critical airway surgery based on their experience.

Potential risks

There are risks and adverse events related to all extracorporeal life support (ECLS) procedures and
anticoagulation, including: heart, vessel, or lung damage, hypoxia or hypercarbia due to inadequate gas
exchange, anemia, infection, hemorrhage, liver or kidney failure, stroke, and death.

See the individual device IFUs for device-specific risks and potential adverse effects.

AP40, BBAP40, CBAP40

Potential complications, including those normally associated with ECLS procedures and anticoagulation,
may necessitate physician intervention. Some potential complications related to the use of ECLS pumps
include, but are not limited to: air embolism, thrombus formation leading to deep-vein thrombosis or
pulmonary embolism, hemolysis, thrombocytopenia, mechanical failure of pump or connections,
infection, hypothermia or hyperthermia due to inadequate heat transfer, hemorrhage related to
bleeding, and inadequate blood flow related to clotting or hypovolemia resulting in inadequate gas
exchange.

Clinical signs or observations that suggest device changeout is necessary

AP40, BBAP40, CBAP40

The blood pump should be evaluated for changeout if the clinician determines during the extracorporeal
procedure that adequate patient support is not being achieved. Examples of device performance-related
indications that a changeout is needed may include an audible grinding noise with vibration caused by
bearing failure, or severe hemolysis. Use of adequate anticoagulation and reduced RPM during ECMO
can help reduce the chances of bearing failure.

If a changeout is deemed necessary, obtain a replacement device before discontinuing circulation
through the original device. Have the materials needed for the change available before starting the
change, including clamps and sterile scissors. Always use aseptic technique during change out.

1

The published article used 14.43 inadvertently.

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To change out the pump:

1. Reduce pump flow down to a low RPM value just prior to clamping the pump outlet and pump
inlet lines.

2. Double clamp both the pump outlet tubing, followed by the pump inlet tubing. Clamp far
enough away from the pump outlet/inlet to allow adequate room for reconnection to the
replacement device.

3. Decrease RPM down to zero to stop the pump.

4. Remove the pump from the drive motor.

5. Using aseptic technique, cut the patient blood drainage line and patient blood return line
between the clamps connected to the original blood pump.

6. Connect the new device using air-free technique. Connect the patient blood return line to the
pump outlet, and the patient blood drainage line to the pump inlet of the replacement blood
pump.

7. Secure pump inlet and outlet tubing connections with tie bands, per institution protocols.

8. Insert new pump back into drive motor, then secure.

9. Open the clamp on the pump inlet side and turn on the pump at a low RPM speed.

10. Confirm that the system is free of air before removing the pump outlet clamp, and gradually
increase the pump flow to the desired RPM value.

Use conditions

The intended users are patients who are experiencing acute respiratory failure or acute
cardiopulmonary failure, and the duration of use is likely to extend beyond the labeled 6-hour
indication. There are no other changes to the intended use as described in the instructions for use for
these devices. There are no changes to the contraindications as described in the instructions for use for
these devices.

AP40AST

Use the Stöckert and Sorin centrifugal pump systems and the Sarns and Terumo centrifugal systems as
described in the instructions for use accompanying each device.

Medtronic, Inc.

710 Medtronic Parkway
Minneapolis, MN 55432
USA

M005852C001 A
© 2020 Medtronic

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