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.
UPDATE – On December 5, 2022, the LivaNova (TandemLife) notified customers through Urgent Medical Device Communication letters that a software update has been developed to address the issue of unintended pump stops for the LifeSPARC System. The only action required by the customer will be to make their equipment available for the third-party representative from MERA to perform the update and sign off on the form once the upgrade is completed.
- Product Name: LifeSPARC System
- Product Model: LifeSPARC Controller, Model LS-1000
- Distribution Dates: December 19, 2019 to present
- Devices Recalled in the U.S.: 484
- Date Initiated by Firm: July 21, 2022
The LifeSPARC System is intended to pump the blood through an extracorporeal circuit for periods lasting less than 6 hours for the purpose of providing either:
- Full or partial cardiopulmonary bypass (i.e., circuit includes an oxygenator) 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.
Reason for Recall
LivaNova (TandemLife) is recalling the LifeSPARC Controller, part of the LifeSPARC System due to a software malfunction. 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. 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.
Who May be Affected
- People who receive care using the LifeSPARC System.
- Health care personnel providing care for patients with the LifeSPARC system.
What to Do
On July 21, 2022, LivaNova (TandemLife) sent customers an Urgent Medical Device Communication. The letter recommended 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, including:
- Ensure batteries are charged, properly installed, and power source (A/C or battery) is verified.
- Turn on and power up replacement controller.
- Select Pump Settings Screen to adjust speed.
- Disconnect pump drive line from malfunctioning controller and plug the pump drive line into the replacement.
- Start pump on replacement controller.
- Attach flow sensor to replacement controller.
- Report system or critical failure to LivaNova.
- Use an external flow measurement system until controller replacement is complete if flow rate needs to be monitored during a critical failure.
- Contact LivaNova Clinical Support for guidance and support at (800) 373-1607 or (412) 579-6182.
For sites that use the LifeSPARC System:
- Ensure a backup controller (including dock, batteries, and power cord) are available.
- Replace Operations Manuals revision 14 or earlier with the revision 15 (enclosed with the letter), which clarifies the instructions for replacing the controller during a critical failure.
- Return the response form attached to the letter to LivaNova.FSCA@livanova.com.
- Communicate these instructions to all healthcare personnel who use this device.
Customers with questions regarding this recall should contact their LivaNova representative or LivaNova Customer Quality at LivaNova.FSCA@livanova.com.
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using an online form, regular mail, or FAX.