FDA safety alerts flag cardiac devices
Editor's Note The US Food and Drug Administration (FDA) issued early alerts August 6 for three medical devices due to safety concerns: Medline ReNewal’s reprocessed St. Jude Medical electrophysiology catheters, Boston Scientific’s ENDOTAK RELIANCE defibrillation leads with ePTFE-coated coils, and Boston Scientific's WATCHMAN Access Systems. The Medline alert involves specific lots…
FDA issues Class I recall for Philips BiPAP ventilators
Editor's Note Philips Respironics BiPAP A30, A40, and V30 Auto ventilators are subject to a Class 1 recall—the US Food and Drug Administration’s (FDA’s) most severe category indicating risk of serious injury or death—due to the risk for a failure in the Ventilator Inoperative alarm, which can cause therapy interruption…
FDA designates Class I recall for arterial cannulae due to exposed wire risk
Editor's Note The US Food and Drug Administration (FDA) has designated a Class I recall—the most severe category indicating risk of serious injury or death—for several models of arterial cannulae manufactured by Edwards Lifesciences. Affected products include OptiSite Arterial Perfusion Cannula models OPTI16 and OPTI18, as well as Peripheral Femoral…
FDA designates Class I recall for mobile lift component
Editor's Note The US Food and Drug Administration (FDA) has designated Baxter’s recall of the Q-Link 13 mobile lift component a Class I, the most severe category indicating risk of serious injury or death. As detailed in the agency’s July 23 announcement, the optional component connects to sling bars on…
FDA issues safety alert for Baxter Novum IQ large volume pumps
Editor's Note The US Food and Drug Administration (FDA) issued an early alert for Baxter’s Novum IQ Large Volume Pumps (Model 40700BAXUS) due to potential for underinfusion when transitioning from a flow rate to a higher flow rate (eg, rate change or bolus). According to the agency’s July 22…
FDA issues early alert for microbore extension sets
Editor's Note B Braun Medical is recommending certain microbore extension sets—single use, disposable, add-ons for infusion, injection, or aspiration—be removed from anywhere they are used or sold, according to a July 17 announcement from the US Food and Drug Administration (FDA). According to FDA’s early alert, the recall was motivated…
FDA designates Class 1 recalls for EVH system, infusion pump
Editor's Note The US Food and Drug Administration (FDA) has designated recent recalls of Getinge and Maquet’s VasoView HemoPro 2 (VH-4000 and VH-4001) Endoscopic Vessel Harvesting Systems and BD’s Alaris Pump Module model 810 as Class 1, the most severe category indicating serious risk of injury or death. According to…
Patient falls, wrong surgeries, care delays lead rise in sentinel events
Editor's Note Sentinel events reported to The Joint Commission increased by 12% in 2024, with patient falls once again leading the list of serious adverse events followed by wrong surgeries. The Joint Commission released the data in an annual review July 9. Wrong surgery events increased 13% from the…
FDA early alerts flag pump controllers, software
Editor's Note Recent early alerts from the US Food and Drug Administration (FDA), issued when the agency becomes aware of potentially high-risk issues, involve Abiomed’s Automated Impella Controller (AIC) and infusion pump software from Baxter. The AIC system, which is the user control interface for the Impella catheter blood pump,…
Hidden head injury hazards expose cracks in OR safety culture
One of the most sobering moments in the career of anesthesiologist Cornelius Sullivan, MD, occurred not as a caretaker in the OR, but as a patient in the emergency department. Having been knocked out cold by a low-hanging monitor during a surgical procedure at Boston Children’s Hospital, he had to…
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