Devices

Medfusion Syringe Pump Recalled Over Software

Smiths Medical ASD has recalled (device correction) its Medfusion model 3500 syringe pump due to software-related issues (before version 6). According to a Smiths recall notice, “Issues associated with earlier software versions of the medical pump include a high-priority alarm for delivery during motor not running, restarting infusion with incorrect parameters, screen lock problems, interruptions in bolus or loading dose delivery, incorrect display of bolus/loading dose information, doses falling below the minimum recommended rate, motor rate errors, incorrect recall of last settings, corrupt configurations, auto lock issues, and problems with the toolbox configuration loading dose time values.” There is the potential that the device may fail and result in delay or interruption of therapy if these issues arise during use, it says, adding that one related injury has been reported.

The pump is designed for precise control of infusion rates for fluids such as blood, lipids, drugs, antibiotics, and therapeutic fluids. It can be used in various delivery routes, including arterial, epidural, intravenous, intrathecal, subcutaneous, and enteral, the notice says, adding that the device supports delivery modes like continuous, volume/time, mass, body weight, intermittent, and bolus.

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