Alaris Archives - Medical Design Sourcing

FDA clears updated BD Alaris infusion system after long-term commercial hold

The Alaris infusion system. [Image courtesy of BD]BD (NYSE: BDX) + announced today that the FDA granted 510(k) clearance for its updated Alaris infusion system.

Shares of BDX closed out Friday evening priced at $264.84 each. They ticked up significantly after market close on the back of the Alaris news, rising 5.9% to $280.40 apiece.

Clearance enables both remediation and a return to full commercial operations for the previously maligned infusion system. It covers updated hardware features for the point-of-care unit (PCU), large-volume pumps, syringe pumps, patient-controlled analgesia (PCA) pumps, respiratory monitoring and auto-identification modules.

The updated clearance also covers a new software version with enhanced cybersecurity, plus interoperability features. These enable smart, connected care with the most widely used electronic medical record (EMR) systems.

“The 510(k) clearance of the upda…

BD discloses 8 cybersecurity vulnerabilities with Alaris infusion system

The Alaris system with Guardrails Suite MX. [Image courtesy of BD]BD (NYSE: BDX) + today voluntarily posted a product security bulletin for a number of vulnerabilities with its Alaris infusion system.

Franklin Lakes, New Jersey-based BD recently identified eight vulnerabilities. These vulnerabilities are associated with the BD Alaris system with Guardrails Suite MX, versions 12.1.3 and earlier.

The company discovered the vulnerabilities through routine internal security testing as part of its software development life cycle. This includes vulnerability scanning, code analysis, threat modeling and penetration testing.

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

BD issues vulnerability warning for Alaris infusion monitoring software

BD’s Alaris infusion pump and vital signs monitoring system is designed to deliver controlled amounts of fluid, medication, blood and blood products. [Photo courtesy of BD]BD (NYSE:BDX) today issued a voluntary notification regarding cybersecurity vulnerabilities with its Alaris Infusion Central software.

Alaris Infusion Central, a standalone software — separate from pumps — provides data from the Alaris pumps. It allows healthcare providers to monitor infusion data sent from Alaris Plus and Alaris neXus pumps on a computer. Alaris Infusion Central is not sold in the U.S. Despite similar product family names, the vulnerability does not impact users of the Alaris PCU 8015 or Alaris Systems Manager.

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

BD begins remediation following BD Alaris system software recall

(Image courtesy of BD)

BD (NYSE:BDX) announced today that it will begin remediation for a 2020 recall of its Alaris infusion system.

Franklin Lakes, N.J.-based BD’s remediation for the Feb. 4, 2020, recall of the BD Alaris system will begin through a new version of software after a voluntary recall alerted customers to a number of areas in which the pump may not operate as expected. Those areas included software errors related to System Error Code 255-XX-XXX, delay options programming, low battery alarm failure, keep vein open/End of Infusion alarms priority and user errors related to Customer Concentrations Programming.

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

BD’s Alaris pump hit with another recall

(Image courtesy of BD)

A medical supply company is recalling BD (NYSE:BDX) Alaris infusion pumps — the third such recall for the pumps in the past few months, according to the FDA.

North Carolina-based Avante Health Solutions issued the Alaris pump recall March 24, 2021, because the bezel repair posts may crack or separate, leading to the inaccurate delivery of fluids to patients. The separation of one or more bezel repair posts could result in the free flow of fluids to patients, over- or under-delivery of fluids, interruption of fluid delivery, device leaks, device component burning or smoking and/or power supply failure or malfunction.

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

Pump problem prompts another Alaris recall

Days after classifying one recall for the Alaris infusion pump, the FDA has issued another Class I recall for the device.

On Friday of last week, the FDA issued a Class I recall — the most serious kind — for the BD (NYSE:BDX) Alaris because there is a risk of the keypad lifting up due to fluid entry, an issue that could result in keys that become unresponsive or stuck. BD initiated that recall on March 3, 2021.

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