Devices

Baxter Class 1 Recall on Sigma Infusion Pumps

FDA has classified as Class 1 a Baxter Healthcare recall of its Sigma Spectrum Infusion Pumps with Master Drug Library (Version 8) and Spectrum IQ Infusion Systems with Dose IQ Safety Software (Version 9) due to the risk of the devices not sounding alarms for repeated upstream occlusion events. The devices are intended to deliver through infusion tubing sets controlled amounts of fluids such as drugs, blood, blood products and other patient therapies.

“After an upstream occlusion alarm, failure to fully resolve any upstream occlusion before restarting the infusion can cause the pump to not re-alarm as expected,” a recall notice says. “The pump adjusts occlusion detection after the user acknowledges an upstream occlusion alarm; for the remainder of that infusion, the upstream occlusion alarm will not alarm per its baseline settings.” The notice says patient harm can happen from interruption in therapy (due to full occlusion) or underinfusion (due to partial occlusion). Baxter has received 51 serious injury reports and three patient deaths over the past five years that may be associated with the issue.

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

Read more

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