Devices

BD Recalls Alaris Pump Due to Infusion Sets

BD and subsidiary CareFusion have issued an “Urgent Medical Device Recall (Correction)” letter about performance issues, under certain use cases, for the BD Alaris Pump Module model 8100 when used with a subset of compatible pump infusion sets. “BD stated that they have identified a subset of compatible pump infusion sets that may perform outside the performance ranges published in the user manuals for flow rate and bolus accuracy, downstream and upstream occlusion time to alarm, and post-occlusion bolus volume (POBV),” an agency safety alert says.

The deviations in performance from earlier published ranges are attributable to these pump infusion sets’ design features, such as filters and other in-line components, FDA says. “Filters with very fine pores (i.e., 0.2 micron) and other in-line components (i.e., back check valves and Y-sites) may impact performance such as flow rate accuracy and time to alarm, particularly at very low flow rates,” it adds.

The BD Alaris pump is described as a modular infusion pump and monitoring system for the continuous or intermittent administration of fluids to adult, pediatric, and neonatal patients through clinically accepted routes of administration: intravenous, intra-arterial, subcutaneous, epidural, or irrigation of fluid spaces, according to FDA.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome