Heartware Fails to Correct Earlier Warning Letter, 483 Observations

A May 17 to July 12 FDA inspection found that Miami Lakes, Florida-based devicemaker Heartware fell short on repeated quality system observations that were cited in a 2014 warning letter and a 2016 FDA Form 483.

The 16-page 483 highlighted numerous system quality issues for the firm’s ventricular assist device (HVAD). The device was recalled in June due to an unintended disconnection of the power source.

The firm had not established design control procedures in that design input requirements don’t always translate into a final design output following validation activities. For example, several CAPAs and quality plan activities were opened in reference to design requirements but the firm reported device failures related to inadequate implementation of design controls.

Numerous CAPAs related to connector bent or damaged connector socket pins on power connector ports, and investigations into the causes of the bent pins and connectors showed continuing failures of the firm to address the root causes.

“Your firm failed to implement [CAPAs] in that a broad-based systemic approach, going across product lines, processes, and quality management systems when investigation and developing corrective/preventive action plans was not always used,” the agency said.

The firm also fell short on complaint handling procedures and medical device reporting procedures were not implemented. In addition, Heartware failed to adequately train personnel, and it’s HVAD risk assessment documents were not updated.

Read the 483 here: www.fdanews.com/11-20-18-heartwareinc483.pdf.