HeartSine has received a warning letter from the U.S. Food and Drug Administration (FDA) over its medical device reporting and tracking violations at a Pennsylvania facility, Mass Device reports. The warning is more bad news for the company; late last year, the FDA issued a Class I recall for HeartSine’s Samaritan defibrillators.
A Class I recall is the FDA’s most serious recall status-it means that exposure to the device could cause serious injury or death.
Now, HeartSine is being cited for its “failure to adequately develop, maintain and implement written [medical device reporting] procedures”. The company has also misbranded its automated external defibrillators, the FDA said. Another citation over late adverse event reporting, which had already been addressed, was also noted in the letter. The FDA’s adverse event reporting system used to keep track and record and complications or injury associated with a drug or medical device.
Several things are wrong with HeartSine’s reporting system, the FDA said. The company had a lack of sufficient documentation, missed some key definitions, had poor recording-keeping and protocols for follow-up with the agency. According to the FDA, HeartSine also “failed or refused” to submit mandatory device documents, including contact information and device tracking system audits. HeartSine also failed to conduct regular tracking system audits, the FDA said.