FDA Class 1 recalls target anesthesia workstations, ambulatory infusion pumps, ventilators

Editor's Note

The US Food and Drug Administration (FDA) has designated Class 1 recalls—the most severe category indicating risk of serious injury or death—involving three systems: Atlan anesthesia workstations from Draeger, CADD-Solis ambulatory infusion pumps from Smiths Medical, and Trilogy Evo ventilators from Philips Respironics. FDA issued all three announcements November 19.

Dreager’s recall of Atlan A350 and A350 XL anesthesia workstations was motivated by a manufacturing error that could result in failure before or during use. Risks to patients include hypoxia, lung recruitment, bradycardia, cardiac arrest, and death, according to the FDA report. Users are advised to closely supervise the devices and switch to manual/spontaneous mode as-needed until the company can replace the ventilator motor assembly. No deaths or injuries have been reported.

Updated instructions for Smiths Medical’s CADD-Solis Li-ion Rechargeable Battery Packs advise users on checking for damage and replacing packs that may have been damaged from battery shorts. Although no injuries or deaths have been reported, FDA notes that this issue could potentially cause burns death due to delayed or interrupted therapy.

Finally, updated instructions for multiple models in Phillips Respironics’ Trilogy Evo line of ventilators advise users to ensure all alarms are set appropriately and maintain alternate systems in the event the systems stop working. According to the FDA announcement, the recall was motivated by the risk of aerosol deposits accumulating over time on the device’s internal flow sensor, resulting in inaccurate flow measurements. For patients, risks include respiratory discomfort, lung damage, dyspnea and death due to therapy delays or the delivery of too much or too little oxygen. Four injuries have been reported.