California Man Dies After Apparent Failure of Artificial Heart Compressor

This article originally appeared on October 20, 2016 Kaiser Health News.

By Anna Gormon

The Food and Drug Administration is investigating repeated problems with a portable compressor for artificial hearts that may have played a role in the death earlier this month of a 57-year-old Orange County, Calif., man.

Officials at Cedars-Sinai Medical Center in Los Angeles, where the man’s artificial heart was implanted, said they believe the apparent failure of the compressor may have caused his death. The hospital said it has stopped using the device with new patients, pending guidance from regulators.

Cedars-Sinai also readmitted two other patients who, like the Orange County man, had been sent home with the compressor. The device, known as the Freedom portable driver, powers artificial hearts and keeps them pumping. It allows even very sick patients to return home, including many awaiting heart transplants.

A spokeswoman for the FDA, which regulates medical devices, said the agency’s inquiry follows recently reported problems related to the Freedom driver. The spokeswoman, Deborah Kotz, said the problems occurred with patients from more than one hospital, though she would not identify the hospitals or what the problems were. It is unclear whether the Cedars-Sinai case triggered the FDA’s investigation.

The agency has asked Arizona-based SynCardia Systems, the manufacturer of the driver and the artificial heart, for more information, including a summary of “adverse events” related to the compressors, according to company CEO Michael Garippa.

In August 2015, SynCardia notified the FDA that it voluntarily was recalling 56 drivers worldwide, including 29 in the U.S., after discovering a problem with a specific component. The next month, the FDA issued a recall of the same 29, warning that certain drivers could fail without warning and cause the patients to lose consciousness.

“The patient will likely experience serious injury or death if not immediately switched to a backup driver by a caregiver,” the recall notice said.

Garippa said the problem that led to the recalls was caused by a supplier who put a screw in the wrong part of the gear box. He also said that only one driver actually stopped, resulting in a patient losing consciousness. The person came to shortly after being switched to a backup driver, and the company replaced the drivers, he said.

The Cedars-Sinai patient, 57-year-old Mark Trudell, died on Oct. 2 after his driver stopped working and he was rushed to the hospital from his home in Huntington Beach, according to his caregiver, Jessie Robledo.

The family believed Trudell was at the top of the list for a donated heart at the time of his death, Robledo said.

“We were waiting for the call,” she said. “He had problems with his heart for many, many years. But we thought he was going to make it.”

Garippa, who stayed on as CEO after SynCardia changed ownership last month following a Chapter 11 bankruptcy, said the company did not know the precise reason for Trudell’s death, but he believes too much time passed before the patient could be switched to a backup driver. He said SynCardia is reviewing the case to determine what happened.