LivaNova (TandemLife) is recalling several hundred parts of its LifeSPARC system due to a software malfunction. The US Food and Drug Administration has identified this as a Class I recall, the most serious type.
The recall pertains to LifeSPARC’s controller used to pump blood through an extracorporeal circuit during full or partial cardiopulmonary bypass, or to divert blood temporarily during open surgery of the aorta or vena cava. LivaNova, which initiated the recall on July 21, 2022, says it involves 484 of the Model LS-1000 devices distributed in the United States from December 2019 to the present.
“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,” the FDA said in the recall notice released today. “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 could cause serious injury or death. LivaNova says there have been 66 reported complaints about the issue, including two patient injuries but no deaths.
The manufacturer recommends that all sites using the system have a backup controller available, replace their operations manual with the new version containing the specific instructions for setting up the backup controller, and communicate the issue and all instructions to healthcare personnel who use the device.
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