B. Braun Archives - Medical Design Sourcing

B. Braun launches luer device for IV infusions

The CareSite Micro luer access device. [Image from B. Braun]B. Braun Medical announced that it launched its new CareSite Micro luer access device designed to make IV access safer.

Bethlehem, Pennsylvania-based B. Braun designed the device to reduce exposure to harmful chemicals. It aims to decrease infection risk in IV access for patients and healthcare providers.

The company says its device is the only needleless connector not made with Bisphenol A (BPA). This harmful chemical can potentially cause multi-organ toxicity. Instead, B. Braun designed CareSite Micro with a drug-resistant material. It helps reduce the risk of infections and drug exposure from stress cracks associated with material and drug incompatibility.

B. Braun developed the device to reduce the prevalence of hospital-acquired bloodstream infections. These are often associated with catheter insertions and remain a major cause of morbidity and mortality. CareSite Micro features a smooth, flat…

B. Braun infusion pump battery recall is Class I after one reported death

The Infusomat Space large-volume pump. [Image from B. Braun]The FDA labeled a recall of B. Braun Medical infusion pump battery packs Class I, the most serious kind.

B. Braun’s recall is a correction, not a product removal, affecting the battery pack for its Infusomat Space large-volume pump. It affects both wireless and non-wireless batteries, model numbers 8713051U and 8713052U.

According to an FDA notice, the company recalled the infusion pump system due to faulty occlusion alarms. On certain models, an occlusion alarm may sound when no occlusion exists, causing the pump to stop the delivery of medications. That includes high-risk medications like vasopressors.

Interruption to high-risk medication delivery could lead to hemodynamic instability requiring medical intervention to prevent impairment to body structures or body functions. In some cases, this could lead to life-threatening circumstances or death.

Get the …

B. Braun recalls some two-piece syringes due to potential packaging barrier damage

Certain Injekt syringes fall under this recall. [Image from B. Braun]B. Braun issued an urgent field safety notice in Europe related to potential issues with certain two-piece syringes.

The company’s notice said it decided to proactively recall a batch combination of the syringes. B. Braun identified a number of batches of its Exadoral, Henke-JECT, Norm-Ject and Injekt devices.

In the course of postmarket surveillance and internal quality checks, the company identified the reason for the recall. For a subset of the batch combinations, the sterile packaging barrier may be damaged.

Get the full story at our sister site, Drug Delivery Business News.

B. Braun launches DoseTrac Enterprise infusion management software

B. Braun today announced it launched its next generation of infusion management software, called DoseTrac Enterprise.

The new software allows organizations to receive a mix of real-time views and retrospective reporting features better to understand their infusion pump fleet and associated data.

DoseTrac Enterprise can connect up to 40,000 pumps at an unlimited number of facilities with just one application, according to the company. It allows customers to manage their infusion pumps from a single, central application, regardless of the size of their fleet or number of locations. Pumps can be moved between locations seamlessly and data can be aggregated and disaggregated from the enterprise level down to the individual facility care area to assist with continuous quality improvement.

DoseTrac helps improve data management to lead to a decrease in clinical IT infrastructure required for infusion pumps.

“We are delighted to introduce our DoseT…

B. Braun buys catheter securement device portfolio from Starboard

[Image from B. Braun]B. Braun Medical announced today that it acquired the Clik-FIX catheter securement device portfolio from Starboard Medical.

Clik-FIX adds to B.Braun’s offerings that help improve patient experiences and outcomes for peripheral intravenous (IV) therapy.

The portfolio includes the Clik-FIX Peripheral, PICC/Central, Universal, Neonatal PICC and Soft PICC/Central systems.

Clik-FIX Peripheral represents an all-in-one integrated securement device with bio-occlusive dressing. It replaces the need for individual tape, gauze and transparent dressings, B. Braun said. Clik-FIX PICC/Central, a universal device, is designed to secure most peripherally inserted central catheters (PICC) and central catheters with an active dual locking mechanism. It represents an alternative to sutures, tape, tape-based stabilization and other securement systems.

The Clik-FIX Universal system stabilizes and secures any medical tubing junction with a Leur …

B. Braun, Infraredx to collaborate on drug-coated balloon catheter IDE study

B. Braun Interventional Systems (BIS) announced today that it is collaborating with Infraredx on a trial for the B. Braun SeQuent Please ReX.

Bethlehem, Pa.-based BIS, a B. Braun affiliate, and Infraredx, a Nipro company, will work together to accelerate the FDA investigational device exemption (IDE) clinical trial for the SeQuent Please ReX drug-coated PTCA balloon catheter, which received breakthrough device designation in 2019.

Get the full story at our sister site, Drug Delivery Business News.

B. Braun appoints new CFO

James Allen (Image from B. Braun)

B. Braun announced today that it appointed James Allen as a senior VP and as the company’s chief financial officer.

Allen, a veteran of more than 30 years in finance and management within multiple industries and disciplines, will replace Bruce Heugel, who last year announced that he would retire after more than 20 years at B. Braun, according to a news release.

Following a transition period, in his new position, Allen is slated to lead all financial operations of the Bethlehem, Pa.-based B. Braun group of companies in North America as they develop infusion and pain management therapies, among other offerings.

“With his strong leadership skills, extensive experience across a wide range of functions, and proven ability to design and implement customer-focused financial strategies to deliver profitable growth, James is ideally qualified to support B. Braun in this critical role,” B. Braun of America chairm…

Medtech takes a stand on D.C. rioting

The medtech industry has joined other business and industry groups in condemning Tuesday’s siege of the Capitol in Washington, D.C. by supporters of President Donald Trump.

The National Manufacturers Association called for Vice President Mike Pence to invoke the 25th Amendment to remove President Donald Trump from office. The Business Roundtable tweeted a call for an end to the violence and for a peaceful transition of power to President-elect Joe Biden’s administration.

Get the full story on our sister site, Medical Design & Outsourcing.

Dems seek to force EPA action on ethylene oxide monitoring

(Image from the U.S. Occupational Safety and Health Administration)

Democrats in both houses of Congress have introduced legislation that would force the U.S. Environmental Protection Agency to better monitor emissions of ethylene oxide (EtO) from plants that manufacture the toxic gas or use it to sterilize medical devices.

The Public Health Air Quality Act of 2020, sponsored by Sen. Tammy Duckworth (Ill.) and Rep. Lisa Blunt Rochester (Del.), would require immediate EPA action to monitor emissions at “facilities contributing to high local cancer rates and other health threats from dangerous pollutants.” The list includes eight medtech sterilization plants included among 25 EPA-designated, EtO-using or -producing facilities:

Get the full story on our sister site, Medical Design & Outsourcing.

B,. Braun, Baxter, CareStream, Green Hills affected by Ripple20 cyber vulnerabilities

The U.S. Cybersecurity and Infrastructure Security Agency (CISA) said it is aware of vulnerabilities affecting Treck IP stack implications for embedded systems.

Known as Ripple20, the vulnerabilities allow a remote attacker to exploit and take control of an affected system, according to the CISA statement.

Among the affected companies were B. Braun, Baxter (NYSE:BAX), Green Hills Software and CareStream. CISA encouraged affected users and administrators to review the affected products for additional information and mitigations, as well as to update to the latest stable version of the Treck IP stack software.

B. Braun issued a statement saying that it is aware of the notification from CISA, sharing that the vulnerabilities exist in the third-party software used for network communication in its Outlook 400ES safety infusion pump system.

The company said it received 24 patches from Treck to resolve vulnerabilities, determining that 20 patche…

Medtech manufacturers must add warning label to drug-eluting PAD devices

UK medtech regulators on Monday announced that manufacturers of paclitaxel-eluting balloons for use in peripheral arteries must add a warning label about the devices’ risks.

A meta-analysis published in the Journal of the American Heart Association in 2018 suggested that patients treated with paclitaxel-coated balloons and stents for peripheral artery disease could be at a higher risk for late death compared to people treated with uncoated balloons. Led by Dr. Konstantinos Katsanos, researchers looked at data from 28 trials and discovered that there was a 68% relative risk increase in all-cause death with paclitaxel-coated devices after 5 years and a 93% relative risk after 5 years compared to therapy with an uncoated balloon.

Labeling changes will apply to instructions for use of these devices throughout Europe and will include a warning and a summary of the Katsanos publication plus supplemented with the clinical data specific to each device. No device…

B. Braun’s top North American executive to retire

Caroll H. Neubauer will retire at the end of August as the head of B. Braun’s North America operations.

B. Braun announced today that Caroll H. Neubauer will retire at the end of August after 24 years leading the Melsungen, Germany–based medical and drug delivery device giant’s North America operations.

Jean-Claude Dubacher, a former Johnson & Johnson and Abbott executive who already took over Neubauer’s role as CEO of B. Braun Medical at the start of the year, has now also assumed Neubauer’s position as chair and CEO of B. Braun of America, effective June 1. Neubauer will stay on until Aug. 31 as executive director of B. Braun of America.

Based in Bethlehem, Pa., B. Braun of America includes B. Braun Medical (also in Bethlehem), B. Braun Interventional Systems, Aesculap and Central Admixture Pharmacy Services (CAPS). Under Neubauer’s leadership, the North America ope…