HeartWare International is responsible for software and design malfunctions that may have led to serious injuries and death, the U.S. Food and Drug Administration (FDA) said in a letter. According to Worcester Business Journal Online, the agency cited 27 complaints of controller failure for HeartWare’s ventricular assist device received by the company. The failure was most likely caused by electrostatic discharge. Two deaths and four serious injuries were included in the complaints.
According to Worcester Business Journal Online, the violations were spurred by an inspection of the company’s production facility in Miami Lakes, Fla. in January. HeartWare began taking actions to remediate the situation, but did not indicate if these actions were effective, the FDA said.
The FDA also accuses the company of failing to implement procedures to address 238 complaints of premature battery failure. HeartWare also did not resolve complaints regarding loose driveline connectors.
The FDA letter also alleged that HeartWare failed to keep proper records of investigations, maintin procedures for validating device design and failed to validate computer software its intended purpose.
The company was given 15 days to correct the violations and explain how to prevent similar situations from occurring in the future.
