LifeSPARC Controller Class 1 Recall

January 19, 2023 Update:

On January 19, 2023, the FDA issued a Class I recall to ensure all LifeSPARC controllers are updated to software version 1.1.5. LivaNova began actively updating all LifeSPARC controllers to software version 1.1.5 with customers on December 5, 2022 and are nearing 100% completion. Software version 1.1.5 was reviewed and cleared by FDA as part of the recent LifeSPARC 510k clearance for ECMO. Customers can reach out with questions about their upgrade by completing the contact form at the bottom of this page.

LivaNova achieved a 100% customer response rate for the LifeSPARC Critical Failure (CF) field action related to the Operations Manual update on November 8, 2022, which was required by FDA.

On July 21, 2022, LivaNova reported a correction to its customers relating to the LifeSPARC controller, and per its 806 report, notified the FDA on August 4, 2022. The correction relates to modifications made to the Operations Manual to address situations during which certain users were unintentionally stopping the pump as a result of what is called a Critical Failure. In response, FDA classified this as a Class I recall. The Company takes this very seriously as patient safety is our top priority.

Critical Error Description

The LifeSPARC system includes a monitoring feature that detects conditions in which the software is frozen or unresponsive. When these conditions are detected, a Critical Failure occurs, and the system clears the controller screen to prevent display of unreliable data. The system also triggers an immutable alarm.

During the Critical Failure, the pump will continue to run at the set speed as indicated by the LEDs on the secondary display and the speed can still be adjusted using the up / down arrow buttons.

If a Critical Failure occurs, the controller screen cannot be restored, and the alarm cannot be muted.

The user must replace the controller experiencing the Critical Failure with a new controller as instructed in the Operations Manual (revision 15) to resolve the Critical Failure.

Risk to Health

All LifeSPARC controllers could potentially experience a Critical Failure. When a failure occurs, the pump will continue to run at the set speed and the speed can be manually adjusted with the arrow buttons. However, a new controller is needed as the alarm cannot be muted and pump variables are no longer displayed on the screen. The main risk to the patient is the pump being turned off by the HCP, which would cease to deliver therapy.

How to Manage an Impacted Device

It is imperative that all device operators and patient caretakers read and understand the LifeSPARC Operations Manual, revision 15.

If your center has received the Urgent Medical Device Notification: FA-CP-PIT-2022-003, please review and acknowledge receipt as per the instructions.

FDA is not requiring that LivaNova remove the LifeSPARC product from the field. In other words, customers can continue to use the machine. The LifeSPARC device has been deemed safe to use and the FDA agreed with LivaNova’s recall strategy which involved notification to all customers via trackable certified mail of the changes made to the LifeSPARC Controller’s Operations Manual. The changes include specific instructions for use that need to be followed in the event of a controller Critical Failure to mitigate any associated risks to patient health.

Continue to work with your LivaNova Field Representative for in-service training and information regarding the upcoming software upgrades.

If your center does not have a back-up LifeSPARC controller, please contact your ACS Field Representative or complete the contact form at the bottom of the page to discuss LifeSPARC acquisition programs.

Steps to Follow if Your Controller Experiences a Critical Failure

- Sites must ensure a backup LifeSPARC Controller (including dock, batteries, and power cord) is available.

- Watch the instructional video and follow all written instructions below.

Instructions may also be referenced in the LifeSPARC Operations Manual, revision 15 in section 5.2 / System Failure or Critical Failure During Operation and section 5.2.1 / Replacing the Controller.

System or Critical Failure During Operation:

Pump continues to run, do not turn off Controller.

In the event of a SYSTEM FAILURE OR CRITICAL FAILURE during operation (see image below), replacing the Controller will be necessary in order to re-establish full functionality.

The main display screen, during a SYSTEM FAILURE OR CRITICAL FAILURE, may be blank or may freeze as the result of a failure of this type. The MENU and SILENCE Button will be non-functional, and a continuous tone alarm will sound.

The secondary display (see image below) can be used to provide an indication of the Pump Speed. If necessary, Pump speed can be adjusted on the Controller in the failure condition up until it is replaced.

If the Pump was running when the failure occurred, the Controller is designed to maintain the set Pump Speed.

Note: If the Pump was stopped when the failure occurred, it should be able to be started by pressing the PUMP START/STOP button on the Operator Control Panel.

Confirm that the pump is running and that the Pump Speed is being maintained as displayed on the secondary display.

If flow rate needs to be monitored until replacement is complete, it is recommended that an external flow measurement system be utilized.

Replacing the Controller:

Unless a determination has been made to discontinue support, DO NOT DISCONNECT the Pump before following the replacement instructions below.

While steps 1-3 are being completed, continue to use the Controller currently in use; follow steps 1-3 to prepare the replacement Controller.

Ensure batteries are charged, properly installed, and verify power source as A/C or battery for the replacement Controller.
Turn on the replacement Controller and verify successful power up (Controller will automatically proceed to the LOCK screen). Note that the default speed will be 3500 RPM.
Select the Pump Settings Screen to adjust speed.

The replacement Controller is now ready to connect to the Pump.

Disconnect the pump drive line from the existing Controller and plug the pump drive line into the pump drive line receptacle on the replacement Controller.
Start Pump on the replacement Controller.
Attach the flow sensor to the replacement Controller.
Report the System Failure or Critical Failure to LivaNova.
If needed, contact LivaNova Clinical Support for guidance and support at (800) 373-1607 or (412) 579-6182. LivaNova Clinical Support is available 24 hours a day, seven days a week.

Class I Recall: LifeSPARC™ Controller

Steps to Follow if Your Controller Experiences a Critical Failure

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