Pennsylvania-based CardiacAssist landed in the FDA’s cross hairs this month after agency inspectors found that the company failed to file a report after learning of a patient death.
The FDA said that CardiacAssist failed to notify regulators of a patient who died while on the company’s TandemHeart pump. The pump stopped turning after 10 days and attempts to restart it were unsuccessful. The patient died a few days later, according to the FDA memo.
Medical device makers are required to report such incident within 30 days of learning about them. The FDA didn’t say when CardiacAssist was notified of the incident, but said that the company didn’t file the appropriate report.
The medical device maker had already responded to the FDA’s original Form 483 notification regarding the outcome of the inspection, and the agency said that the company’s response was deemed "sufficient" to address the violation.
"We remind you that it is your firm’s responsibility to adhere to its procedures, as well as applicable federal regulations," the FDA noted. "Your firm’s voluntary corrections will be further evaluated during the next inspection at your facility."