LivaNova is recalling the LifeSPARC Controller, which is part of the LifeSPARC circulatory support system, due to a software malfunction where the controller’s monitoring feature may erroneously detect frozen or unresponsive software and trigger the device to enter critical failure mode.
The LifeSPARC System is intended to pump blood through an extracorporeal circuit for periods lasting less than six hours for the purpose of providing either full or partial cardiopulmonary bypass during open surgical procedures on the heart or great vessels; or temporary circulatory bypass for diversion of flow around a planned disruption of the circulatory pathway necessary for open surgical procedures on the aorta or vena cava.
The LifeSPARC System has two components: the LifeSPARC Pump and the LifeSPARC Controller. The LifeSPARC Pump is a single-use pump, and the LifeSPARC Controller provides the interface between pump and user, as well as the power and electrical signals to drive the pump.
Once the device enters Critical Failure mode due to this software malfunction, its clears the controller screen and issues an alarm that cannot be muted or turned off. The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
While the LifeSPARC Pump should continue to run at the set speed with the allowance of manual speed adjustment in Critical Failure mode, the user has to replace the controller using instructions from the operations manual, before disconnecting the pump from the frozen controller, the FDA says. If the user does not follow these specific instructions and powers off the frozen controller prior to acquiring and setting up the backup controller, the pump may stop for an extended period of time during the replacement process.
An extended pump stop during use may cause serious injury or death to the patient.
LivaNova reported that there have been 66 complaints, and the FDA has received two injuries and no deaths due to this issue.
On July 21, 2022, LivaNova sent customers an Urgent Medical Device Communication, recommending users of the device:
- Confirm that the pump is still operating (through secondary display or observing the pump) and that pump speed is being maintained if the screen freezes.
- Continue to control the pump speed using the up and down arrows on the controller.
- Replace any controller experiencing critical failure with a new controller following the instructions in the Operations Manual.
- Use an external flow measurement system until controller replacement is complete if flow rate needs to be monitored during a critical failure.