Medical Device Safety and Recalls: SynCardia Systems, Freedom Driver System – Part May Fail Causing Device to Stop Working

Medical Device Safety and Recalls: SynCardia Systems, Freedom Driver System – Part May Fail Causing Device to Stop Working

A recall has been issued for SynCardia Systems’ Freedom Driver System
. A specific part of the Freedom Driver drive mechanism may fail and cause the device to stop pumping. Patients do not receive any advanced warning that the device may fail. If it does fail, a red light located in the center of the driver, towards the top, will stay red and a loud continuous alarm will sound.

However, if the Freedom Driver stops pumping, the patient will lose consciousness almost immediately, which means that the warning light and alarm may not be helpful. The patient will likely experience serious injury or death if not immediately switched to a backup driver by a caregiver.

Advertisements