Reoccurring problems are being reported about the Freedom portable driver, a device that provides power to artificial hearts. These are thought to have contributed to the death of 57-year-old Mark Trudell from Orange County who received an implant at Cedars-Sinai Medical Center in Los Angeles. He passed in early October after his device stopped working.
Two other patients who received the compressor from Cedars-Sinai Medical Center were also re-admitted to the hospital after the device had complications.
The device is known to fail without any warning, leading to patients becoming unconscious.
“The patient will likely experience serious injury or death if not immediately switched to a backup driver by a caregiver,” the recall said.
The Freedom portable driver is not only meant to provide artificial hearts power, but it helps to support patients who are at home in critical condition, waiting for a heart to become available for a transplant. The device is also designed for patients who are not eligible for a transplant but are in end-stage heart failure. It acts as a heart, replacing the function of all four heart valves as well as both ventricles.
According to Michael Garippa, the CEO of SynCardia (the device manufacturer), the problem was caused by a screw that was installed into a wrong part of the gearbox by a supplier. The design of the heart itself may also lead to complications, due to its various moving pieces.
Patients from other hospitals encountered similar problems with the device. According to SynCardia Systems, 56 drivers were recalled worldwide in August 2015 with 29 of those from the United States. According to 89.3 KPCC, “It is unclear whether the Cedars-Sinai case triggered the FDA’s investigation.”
The FDA is currently investigating these claims while the Freedom portable drivers are no longer being used at Cedars- Sinai Medical Center.