FDA issued BD a warning letter over quality system violations after inspectors found 111 open tickets for software defects the company itself categorized as catastrophic or severe patient harm. The letter also lists safety complaints that missed required reporting timeframes. The findings center on the Pyxis medication management line.
Every software team carries a defect backlog. The problem starts when tickets in the top harm categories sit open long enough for an inspector to count them, because the severity scheme a company writes for itself becomes the yardstick FDA measures it with.
For device software teams the takeaway is operational. Triage deadlines tied to harm category, and complaint handling that feeds the MDR reporting clock, are quality system controls that inspections now read line by line.