FDA reveals HeartWare warning
Federal regulators released a letter that accuses Framingham-based HeartWare International of design and software malfunctions that might have resulted in serious injuries and death.
The U.S. Food and Drug Administration (FDA) said HeartWare received 27 complaints about controller failure for its ventricular assist device, of which electrostatic discharge was determined to be the most likely root cause. The complaints include reports of two deaths and four serious injuries.
The violations stem from a January inspection of the company’s production facility in Miami Lakes, Fla.
The FDA said HeartWare initiated corrective actions but failed to verify or validate their effectiveness.
Likewise, HeartWare stands accused of not adequately implementing procedures to address 238 complaints of premature battery failure, as well as not effectively rectifying complaints regarding loose driveline connectors.
The letter also cited HeartWare for allegedly failing to maintain proper records of investigations, failing to maintain procedures for validating device design and failing to validate computer software for its intended use.
“HeartWare is committed to providing the highest quality products in compliance with FDA regulations to ensure the safety and welfare of patients who rely on our device, and we are dedicated the resources necessary to address the items discussed in the letter,” Doug Godshall, company president and CEO, said in a statement last month.
Regulators gave HeartWare 15 business days from when the letter was sent in early June to correct the noted violations and explain how they plan to prevent similar violations from occurring again. HeartWare was advised last month that a formal warning was on the way.
(Image credit: freedigitalphotos.net)
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