FDA designates recall of pump used in cardiac surgery as class I
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The FDA has designated the recall of a pump used in cardiac surgery as class I, the most serious kind.
LivaNova (TandemLife) recalled the LifeSPARC system, which is used for full or partial cardiopulmonary bypass or temporary circulatory bypass in open surgical procedures because of a software malfunction, according to an agency press release.
The monitoring feature of the controller may erroneously detect frozen or unresponsive software and trigger critical failure mode, requiring replacement of the controller, according to the release.
If during controller replacement, the frozen controller is powered off prior to setup of the backup controller, the pump may stop for an extended period of time, which may cause serious injury or death to the patient, the agency stated in the release.
LivaNova has documented 66 complaints and the FDA has received notice of two injuries but no deaths, according to the release.
In January, the company added the system controller (LifeSPARC Controller) to this recall due to a software update to address the previous malfunction that may erroneously detect frozen or unresponsive software and trigger the device to enter critical failure mode, according to an agency release.
The controller acts as an interface between pump and user and provides power and electrical signals to drive the pump.
The recall affects 589 controllers distributed between Dec. 19, 2019 and Nov. 17, 2022.
Editor’s Note: The article was updated on Jan. 27, 2023 with information regarding the recall of the LifeSPARC Controller.
Reference:
LivaNova (TandemLife) Adds to Recall for LifeSPARC System that May Experience Unintentional Extended Pump Stops Due to Controller Critical Failure. https://www.fda.gov/medical-devices/medical-device-recalls/livanova-tandemlife-adds-recall-lifesparc-system-may-experience-unintentional-extended-pump-stops. Published on Jan. 27, 2023. Accessed on Jan. 27, 2023.
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