FDA

FDA Reports HeartWare Device Malfunctioned, Causing Patient’s Death

FDAIn 2011, the Centers for Disease Control and Prevention compiled statistics from a study which revealed that 26.5 million Americans, or 11.5% of the adult population, have been diagnosed with heart disease. Patients with heart-related problems often rely on breakthroughs in the medical community to help save or prolong their lives. From prescription medication to medical devices, to heart transplants, the science related to heart ailments continues to progress at astounding rates.

HeartWare International, Inc., based in Framingham, Massachusetts, is a global company that designs and manufactures medical devices for patients experiencing heart failure. According to the United States Food and Drug Administration (FDA), one of HeartWare International’s highly visible products was recently determined to have malfunctioned resulting in the death of a patient. The product is known as the HeartWare Ventricular Assist System.

As recently reported by Bloomberg, the patient had the left ventricular assist device for almost three years at the time of its malfunction, which occurred on February 25, 2013. Preliminary analysis revealed that after she had changed the battery, not only did the power drop but the blood flow fell too, causing the controller fault alarm to sound. Reports indicate that the malfunction lasted for three hours before the patient received any help. In the event description, the FDA noted that a family member arrived at the patient’s home and was, at that point, found the patient to be unresponsive. After emergency service personnel performed pulmonary resuscitation, the patient was taken to a local hospital where she died soon after her arrival.

The FDA further reported that an autopsy will be performed, the results of which had not been provided as of the date of the FDA’s event description. At this point, it is not clear what caused the device to malfunction. It has been returned to the manufacturer for further testing and analysis. As news spread of the device malfunction causing a patient’s death, Bloomberg reported that HeartWare stock prices went down 2.5% to $84.15 by 12:34 p.m. in New York. While that may be a concern to those in the financial community, the primary issue is future patient safety and reliability of such a device.

Resources:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=3025979
http://www.bloomberg.com/news/2013-04-05/heartware-device-malfunction-led-to-death-fda-reports.html
http://www.cardiovascularbusiness.com/topics/heart-failure/heartware-patient%E2%80%99s-death-prompts-fda-report