FDA WARNING_LETTER - Cardiac Assist, Inc - February 07, 2014

On May 13, 2014, the FDA issued a Warning Letter to Cardiac Assist, Inc. following an inspection from January 24, 2014, to February 7, 2014. The inspection revealed that the firm's TandemHeart PTVA Blood Pump and TandemHeart Escort Controller are misbranded under Section 502(t)(2) of the Act, due to a failure to furnish required material or information under Section 519 and 21 CFR Part 803 - Medical Device Reporting.

A significant violation identified was the failure to submit a Medical Device Report (MDR) to the FDA within 30 calendar days of becoming aware of information suggesting a device may have caused or contributed to a death, as required by 21 CFR 803.50(a)(1). Specifically, the firm was aware of a complaint where a TandemHeart pump stopped turning, and the patient subsequently died, but no MDR was filed.

The FDA acknowledged the firm's February 26, 2014, response to the FDA-483 appeared sufficient for Quality System deficiencies, but emphasized adherence to procedures and regulations. The letter mandated prompt corrective action to prevent regulatory actions like seizure, injunction, or civil money penalties. Cardiac Assist, Inc. was required to notify the FDA in writing within fifteen business days of the specific steps taken to correct