Devices

FDA Looking at Balloon Pump Shutdowns

FDA says it is evaluating recent reports of Getinge’s Maquet/Datascope intra-aortic balloon pump devices shutting down while running on battery power. A letter to healthcare providers says the devices are used on critically-ill patients in healthcare facilities, including during transport. “An interruption in treatment can result in serious patient injury or death,” the notice says.

The letter says that since 2017, the agency has received over 75 medical device reports of Maquet/Datascope devices shutting down while running on battery, leading to pump stop and loss of hemodynamic support. Five of the reports described three patient deaths, it says, although the deaths cannot be definitively attributed to the device malfunctions. Other reports have described serious patient injuries.

In addition to device shutdown, FDA says, there are reports describing several other battery issues that could lead to patient harm, such as the device not charging the battery, the battery charge indicator not working properly or not showing the correct status of the battery charge, or the battery depleting sooner than expected.

The letter includes recommended actions for healthcare providers.

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