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.