LivaNova (TandemLife) Adds to Recall for LifeSPARC System that May Experience Unintentional Extended Pump Stops Due to Controller Critical Failure
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.
- Product Name: LifeSPARC System
- Product Model: LifeSPARC Controller, Model LS-1000
- Distribution Dates: December 19, 2019 to November 17, 2022
- Devices Recalled in the U.S.: 589
- Date Initiated by Firm: December 5, 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 update being available to address the previous software malfunction that 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. This recall is an addition to a previous recall for the same issue, LivaNova (TandemLife) Recalls LifeSPARC System for Risk of Unintentional Extended Pump Stop During Controller Critical Failure.
The current recall provides information about a software update now available to address this issue.
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 December 5, 2022, LivaNova (TandemLife) began notifying customers about the availability of a software update to resolve the critical failure issue. The letter included the following information for customers/users.
- Customer will be contacted by third-party firm MERA in advance of the software upgrade.
- Users will need to make their units available for the upgrade.
- For machines in use at the time that MERA is onsite to install upgrades, the upgrade will be re-scheduled.
- Customers will need to sign a form presented by the MERA representative after the update is completed.
- Communicate this information to healthcare personnel who use this device.
Until the device is updated with the new software, please continue to follow the recommended actions outlined in the previous recall:
- 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 which clarifies the instructions for replacing the controller during a critical failure.
- Communicate these instructions to all healthcare personnel who use this device.
Customers with questions about this recall should contact their LivaNova representative or LivaNova Customer Quality at LivaNova.FSCA@livanova.com.
- Medical Device Recall Database entry
- LivaNova (TandemLife) Recalls LifeSPARC System for Risk of Unintentional Extended Pump Stop During Controller Critical Failure (September 2022)
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.