FDA 483 - CareFusion 303, Inc. - May 22, 2024

CareFusion 303, Inc. underwent an FDA inspection from May 6 to May 22, 2024, at its San Diego medical device manufacturing facility, resulting in a Form FDA 483 detailing significant quality system deficiencies. The primary issues observed involve inadequate corrective and preventive action (CAPA) procedures. Specifically, the firm initiated a Class I recall for its Alaris Infusion System due to incorrect infusion rates with certain syringes, revealing insufficient validation for syringe compatibility and conflicting product labeling. Additionally, 71 complaints regarding bent connectors in Alaris infusion pumps, some causing patient harm, lacked proper investigation for root causes. There were also 544 open software defects for Pyxis MedStation ES and Anesthesia Station ES, with 111 classified as potentially causing catastrophic or severe patient harm, for which no corrective actions have been implemented. Furthermore, complaint handling procedures were found to be deficient. The company failed to evaluate numerous complaints for Medical Device Report (MDR) submission, including issues with Pyxis MedStation ES network connectivity (affecting multiple hospitals and posing catastrophic harm risk) and electrical safety problems with Pyxis MedBank Automated Dispensing Cabinets. Investigations were often absent for non-MDR complaints, even those reporting delays in medication delivery or wrong medications dispensed with patient harm. The inspection also highlighted failures in timely MDR submission, as 15 complaints, some involving patient harm and even death related to Pyxis Medication Management Systems, were not reported within the required 30 days. Finally, risk analysis for the MedStation ES and MedBank systems was deemed inadequate, failing to incorporate postmarket data (e.g., patient deaths) into hazard assessments, demonstrate electrical safety compliance, or establish a process for assessing cybersecurity vulnerabilities. CareFusion 303, Inc. must address these critical observations by enhancing its quality system to ensure robust CAPA implementation, comprehensive complaint investigation, accurate and timely MDR reporting, and thorough risk management processes, adhering to regulatory requirements for medical device manufacturers.