Federal regulators are investigating a cardiac device after the death of a patient in Los Angeles.
Cedars-Sinai Hospital alerted the U.S. Food and Drug Administration this month about the device, called the SynCardia Freedom portable driver, after a patient with the device died, hospital officials said.
“The apparent failure of the Freedom Driver — a portable, external pump that powers an artificial heart — resulted in the death of a patient,” hospital officials told ABC News in an email.
Neither the FDA nor Cedars-Sinai disclosed when the patient died.
The Freedom portable driver pump is attached to the SynCardia Total Artificial Heart to help patients whose own hearts have stopped working effectively. The portability of the pump allows qualified patients to wait at home for a heart transplant. The longest time a patient successfully remained on the SynCardia Total Artificial Heart is 1,374 days before receiving a successful heart transplant, according to the SynCardia website.
After the death of the patient, hospital officials asked other patients to come into the hospital to either remove the device in exchange for another version or to be monitored in the intensive care unit, according to hospital officials. In total, five patients at Cedars-Sinai were on the device as a stopgap measure as they waited for a heart transplant. Three of the patients were switched to a hospital console device to help pump the blood and two remained on the Freedom Driver device, since they were not healthy enough to switch devices, according to Cedars-Sinai.
“Until there is guidance from the FDA or other regulatory agencies, Cedars-Sinai has stopped using the Freedom Driver with any new artificial heart patients,” a spokeswoman for the hospital told ABC News.
The FDA gave clarification for providers today, acknowledging that the agency is studying the Freedom device system. According to the FDA, there have been reported instances of Freedom Driver “device malfunctions,” which have resulted after “sudden cessation” of the pump without “warning alarms or recognizable signs of impending malfunctions.”