FDA Announces Critical Recall of B. Braun Medical’s Infusion Pump Systems
On November 17, 2023, the U.S. Food and Drug Administration (FDA) emphasized the gravity of a recent recall by B. Braun Medical Inc., labeling it as a matter of utmost concern. The Pennsylvania-based company initiated a recall of certain models of its Infusomat Space Volumetric infusion pump system in September. This action was necessitated due to malfunctioning occlusion alarms in these devices, which could lead to premature stopping or interruption in the delivery of medications.
Occlusion alarms in infusion pumps are critical components that alert when the pump can’t maintain the designated flow rate, leading to increased pressure in the line. The significance of this issue is heightened considering the type of medications these pumps administer. They are often used for delivering vasopressors, which are vital for patients with low blood pressure as these drugs work to narrow or constrict blood vessels. Any interruption in administering such high-risk medications can have dire consequences, potentially being life-threatening or even resulting in death.
The recall’s seriousness is further underscored by the reports received by the FDA. To date, there have been 51 complaints regarding this issue, including one injury and a fatality linked to the recalled infusion pump system. In response to these concerns, B. Braun Medical Inc. has advised its customers against using the affected devices for administering high-risk medications. The company recommends that these pumps should now only be used for low-risk medicine deliveries.
The scope of this recall is considerable, with around 10,655 devices being affected. These recalled units were distributed over a period stretching from October 26, 2022, to July 17, 2023. This recall highlights the critical nature of medical device functionality and the stringent need for continuous monitoring and quality assurance in medical equipment to ensure patient safety.
Individuals who have suffered harm due to the malfunctioning of B. Braun Medical Inc’s Infusomat Space Volumetric infusion pump system may have grounds to pursue legal action for compensation. In these circumstances, a product liability lawsuit could be an appropriate course of action. This type of legal claim is specifically designed to hold manufacturers accountable for injuries caused by defective or unsafe products.
Initiating a product liability lawsuit involves a series of complex steps, where the plaintiff must prove that the infusion pump was defective and that this defect directly caused their injury or harm. This process typically requires the collection of comprehensive evidence, such as medical records, expert witness testimonies, and details about the product’s malfunction. Given the complexities and the often formidable legal resources of manufacturing companies, having an experienced attorney is essential for navigating this process successfully.
An attorney’s role is pivotal in guiding victims through each phase of the lawsuit, from drafting and filing the claim to representing their interests in court proceedings. Legal representation is especially crucial in facing the advanced defense tactics usually employed by companies in product liability cases. Additionally, an attorney can aid in settlement negotiations or provide robust representation at trial, if necessary.
In a successful product liability lawsuit related to the recalled infusion pump system, victims may be able to recover various forms of damages. These can include reimbursement for medical expenses, compensation for lost wages if the injury impacted their ability to work, and monetary relief for pain and suffering. In certain situations, punitive damages may also be awarded, particularly if the manufacturer’s negligence in ensuring product safety is evident.
CONTACT PARKER WAICHMAN LLP FOR YOUR FREE CASE REVIEW
If you or a loved one has been adversely affected by the recalled B. Braun Medical infusion pump system, you may be entitled to legal recourse. Parker Waichman LLP, a renowned national product injury law firm, offers expert legal services in such cases. Their team of experienced attorneys is ready to provide you with a free consultation to assess your situation and discuss your legal options. To learn more about your rights and the steps you can take, call Parker Waichman LLP today at 1-800-YOUR-LAWYER (1-800-968-7529). You don’t have to face this challenging situation alone; professional legal support is just a phone call away.
Regardless of your location or where your injury occurred, our nationwide personal injury law firm is ready to assist you.