FDA EIR - Smiths Medical ASD, Inc. - April 23, 2014

An FDA inspection of Smiths Medical ASD, Inc. in Saint Paul, MN, conducted from April 8 to April 23, 2014, identified significant compliance deficiencies concerning its Class II medical devices. The inspection, initiated "For Cause" due to a recent recall and consumer complaint, revealed three primary violations. Firstly, the company failed to submit Medical Device Reports (MDRs) within 30 days for six Medfusion 4000 syringe pump malfunctions involving electrical shorts, smoking, melting, or fires, with three devices catching fire in critical care settings. These incidents could cause serious injury, violating 21 CFR 803.50(a)(2). Secondly, Smiths Medical did not submit the required 806 report to the FDA within 10 days of initiating the recall for these Medfusion 4000 infusion pumps (21 CFR 806.10(b)). The decision for recall was made on September 9, 2013, but notification to the FDA occurred on November 15, 2013. Thirdly, the firm's corrective and preventive action (CAPA) procedures were deemed inadequate (21 CFR 820.100(a)), as actions taken were not commensurate with the risk of electrical shorts and thermal events. This included delays in conducting and approving risk reviews and control meetings, and a lack of required due dates for corrective actions. Smiths Medical acknowledged these observations, submitted the overdue MDRs, and stated they had revised their recall and risk management procedures to incorporate stricter timelines; however, these corrections were reported but not yet verified by the FDA.