Devices

BD Alaris Pump Software Being Corrected

Becton, Dickinson is correcting software (Class 1 recall) for the BD Alaris Systems Manager and BD Care Coordination Engine Infusion Adapter after receiving reports that customers running both may experience delayed system response and backlogging of automated programming requests (APRs). “After the delay, outdated APRs may upload to the Alaris computer, presenting different rate, dose, or volume parameters than the current infusion,” a recall notice says. “If the outdated rate/dose change is accepted by the user, a patient could receive inaccurate therapy including over- or under-infusion.”

The notice says the issue may cause serious adverse health consequences, including complications caused by the sudden pump stoppage or by receiving too much or too little therapy, causing death. To date, no injuries have been reported.

The Alaris infusion pump and monitoring system provides continuous or intermittent fluids such as medication, red blood cells, or other blood products to adults, children, and infants, according to the company.

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