Device maker LivaNova (TandemLife) has recalled the LifeSPARC controller, part of the LifeSPARC system, because of a software malfunction that may cause the controller’s monitoring feature to wrongly enter critical failure mode, causing the pump to stop working.
The US Food and Drug Administration (FDA) has labeled this a Class I recall, the most serious type, because of the risk for serious injury or death.
LivaNova has received 66 complaints over this issue, and the FDA has received two reports of injuries but no deaths.
The recall includes 484 LifeSPARC controllers (Model LS-1000) distributed between December 19, 2019 to the present.
Advanced Circulatory Support
The LifeSPARC system is intended to pump blood through an extracorporeal circuit for 6 hours or less for one of two purposes:
Providing either full or partial cardiopulmonary bypass during either open surgical procedures on the heart or great vessels
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 system has two components — a single-use pump and a controller that provides the interface between pump and user, as well as the power and electrical signals to drive the pump.
According to a notice posted on the FDA website, the controller’s monitoring feature may “erroneously detect frozen or unresponsive software and trigger the device to enter critical failure mode — clearing the controller screen and issuing an alarm that cannot be muted or turned off.”
“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,” the agency warns.
LivaNova (TandemLife) has sent customers an urgent medical device letter, recommending that users take the following immediate actions:
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.
Customers are asked to contact LivaNova clinical support for guidance at (800) 373-1607 or (412) 579-6182.
Customers with questions regarding this recall should contact their LivaNova representative or LivaNova at LivaNova.FSCA@livanova.com.