Devices

Alert on AquaFlexFlow Blood Circuits

FDA has issued a safety alert on Nuwellis’ AquaFlexFlow UF 500 Plus extracorporeal blood circuit, which is used with the Aquadex SmartFlow and FlexFlow Systems, because the device may trigger a “weight mismatch” alarm while in use. “If too many weight mismatch alarms occur, the Aquadex console will terminate therapy with that blood circuit,” the alert says. “If therapy is terminated, it could cause excess fluid removal from a patient, leading to acute volume depletion, which could also be referred to as hypovolemia or dehydration, which is especially serious in pediatric patients.”

The AquaFlexFlow UF 500 Plus is described as a single use blood circuit set used with the Aquadex SmartFlow Systems, which are indicated for continuous ultrafiltration therapy in adult and pediatric patients whose fluid overload is unresponsive to medical management, including diuretics.

The company says that a new blood circuit must be primed if continued therapy is desired. To date, Nuwellis has reported three injuries 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