The FDA issued an adverse event report describing the death of a patient whose HeartWare ventricular assist device lost power.
According to the agency, the FDA received a report on March 28 about a patient who was found in her home unresponsive with the device alarm sounding. Emergency workers were called and performed cardio-pulmonary resuscitation before taking her to a local hospital. She died soon after in the hospital.
“A preliminary log file analysis revealed that shortly after changing her batteries, the patient experienced a controller fault alarm followed by a sustained drop in flow and power,” according to the report in the FDA’s Manufacturers and User Device Experience database. “This condition persisted for approximately three hours before intervention.”
The incident occurred on Feb. 26. An autopsy was performed and the device was returned to the manufacturer. Framingham, Mass.-based HeartWare reported that it will release findings from its analysis within 30 days.
In February, the company initiated a voluntary field correction advising healthcare professionals to inspect the driveline connector housing of a pump during routine clinic visits due to a potential safety concern. None of the 11 confirmed events resulted in harm to the patient, according to the company.