FDA 483 - CareFusion 303, Inc. - April 06, 2020

The FDA inspected CareFusion 303, Inc., a medical device manufacturer in San Diego, CA, from March 2 to April 6, 2020. The inspection revealed eight observations regarding their quality system and manufacturing processes for medical devices, including the Alaris Infusion system.

Key observations include: 1. **Inadequate Corrective and Preventive Action (CAPA) Procedures:** A CAPA (CA-2018-0161) initiated for inter-unit interface (IUI) connector failures due to corrosion/contamination, which can interrupt communication or power to infusion modules, had a risk assessment that concluded "extremely low" patient harm probability. This conclusion failed to consider a complaint (MDR #2016493-2015-00154) where a communication failure contributed to a patient's death. 2. **Inadequate Complaint Handling Procedures:** Between June 2018 and March 2020, 47,951 Alaris Infusion system complaints lacked documentation of Medical Device Report (MDR) reportability determination. This includes 39 complaints of over/under infusion. 3. **Incomplete Device Software Validation:** The software development procedure lacks a requirement for testing according to reviewed and approved test cases. Additionally, the issue tracking system is used for non-software related issues without established procedures for timely investigation and effective corrective