Baxter Archives - Page 4 of 11 - Medical Design Sourcing

Baxter’s smart incontinence pad system has an RF problem

The WatchCare system is a smart incontinence pad that integrates into healthcare facility beds. [Image courtesy of Baxter]Baxter (NYSE: BAX) recently announced an Urgent Medical Device Correction for its WatchCare incontinence management system.

The Oct. 21 announcement said that the WatchCare system was meant to comply with the most recent radio frequency standards. However, it appears to radiate RF that may affect other devices on caregivers and patients.

In all but two of the reports of problems, interference took place at a distance of less than 1 meter. Examples of potentially serious problems include:

Insulin pumps overdosing insulin due to incorrect high glucose readings; “Phantom” incorrect fetal heart tone readings on fetal monitors; Problems with telemetry devices, bladder scanners and infusion injection pumps.

Baxter has no reports of injuries or death related to WatchCare’s RF.

The company is telling users and faciliti…

Baxter issues Class 1 recall of Clearlink Basic Solution Sets with Duovent

The FDA has classified a recall of a Baxter Healthcare product used to deliver hazardous drugs such as chemotherapeutic agents Class 1, indicating that it could cause serious adverse health consequences or death.

The recall covers all lots with product code 2R8403 distributed from October 14, 2020 to June 30, 2022. There are

Baxter announced the recall after receiving 83 customer reports of leaks.

Because the Clearlink Basic Solution Sets with Duovent are used for hazardous drugs, a leak could expose healthcare personnel.

The problem with the affected product lots of the Clearlink Basic Solution Sets could also cause patients to receive insufficient therapy or may lead to the failure of the sterile fluid pathway and infusion with contaminated fluid. In addition, the problem could delay or interrupt therapy and air ingress into the solution set.

There have been no reports of injuries or deaths tied to the product before the recall.

Ba…

Recall of Baxter Clearlink due to risk of leaks is Class I

The FDA announced today that the recall of the Clearlink basic solution set with Duovent from Baxter (NYSE:BAX) is Class I, the most serious kind.

Clearkink with Duovent is part of a system for administering drugs and solutions to patients. The majority of the sets are used for the delivery of hazardous drugs (chemotherapy).

Increased customer reports of leaks led Baxter to recall the Clearlink set. As the majority of the devices are used for hazardous drug delivery, leakage could expose people to the drugs. This means healthcare personnel, patients, and others could potentially be exposed to drugs that may be toxic and/or are irritants.

The company distributed 511,728 devices in the U.S. between Oct. 14, 2020, and June 30, 2022. Baxter initiated the recall on Aug. 9, 2022.

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

Baxter is reportedly considering a sale of its kidney care businesses

Baxter (NYSE:BAX) is reportedly weighing up the divestiture of its renal care services and hemodialysis business.

According to a Bloomberg report, the company is considering splitting with its kidney care businesses as part of a refocusing effort after its $12.5 billion acquisition of Hillrom last year. The outlet cited anonymous sources familiar with the matter.

The sources told Bloomberg that the business units will likely be valued “well under $1 billion” in total. Interest could come from private equity firms, according to the report. Baxter officials declined to comment, Bloomberg said.

Baxter’s renal care business brought in $931 million in revenues in the company’s most recent fiscal quarter (ended June 30, 2022). It develops dialysis machines, infusion pumps and other products. According to Bloomberg, its hemodialysis business brings in approximately $1 billion in revenue but the outlet’s sources claim it isn’t…

The 10 largest medtech employers — and what their employees really think

Employees of the 10 largest medtech employers are happy to be a part of a company that is having a positive impact on patient populations.

That was one major takeaway as MassDevice compiled some current and former employee reviews posted on Glassdoor.

Medtronic, Philips and Johnson & Johnson MedTech top the list of largest medtech employers. The 10 companies we looked at were the largest employers in Medical Design & Outsourcing‘s newest Big 100 report on the largest medical device companies.

Company Employees Medtronic 95,000 Philips 78,189 Johnson & Johnson MedTech 75,000

As with most companies, there are some qualms with corporate bureaucracy and reorganizations creating frustration for employees.

Employment in the medtech industry is on the rise, according to a recent analysis of our Medtech Big 100 data. There were 1,268,924 employees among the 100 largest companies that report human capital in their annual repor…

CISA warns on cybersecurity vulnerabilities for certain Baxter infusion pumps

The U.S. Cybersecurity and Infrastructure Security Agency (CISA) today issued a warning on some Baxter (NYSE:BAX) infusion pumps.

Sigma and Baxter Spectrum infusion pumps are included in a CISA notice over remotely exploitable vulnerabilities. Those vulnerabilities include: missing description of sensitive data, use of externally controlled format string and missing authentication for critical functions.

The successful exploitation of the vulnerabilities could allow access to sensitive data. It could also result in the alteration of system configuration.

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

What are the largest medical device companies?

Medtronic, Johnson & Johnson MedTech and Siemens Healthineers top the Big 100 list of largest medical device companies by revenue.

The 2022 edition of MassDevice and Medical Design & Outsourcing‘s Big 100 report also holds surprises. Big conglomerates are spinning out medtech businesses as stand-alone companies, and that means changes to the list of 100 largest medical device companies.

Colfax, for example, engaged in business moves that turned DJO’s parent into Enovis, a large, stand-alone orthopedic device company that is No. 56 in 2022’s Big 100. ZimVie, formerly Zimmer Biomet’s spine and dental business, is 69th. And after decades under larger corporate umbrellas, Cordis debuts at No. 76 on the list.

We collected thousands of data points to size up the industry’s publicly traded companies and privately held firms. The Big 100 includes annual revenue, R&D spending, employee counts, key leaders, headquarters locatio…

FDA clears syringe infusion pump with Dose IQ software from Baxter

[Image from Baxter website]Baxter (NYSE:BAX) announced today that the FDA issued 510(k) clearance to its Novum IQ infusion pump with Dose IQ safety software.

Deerfield, Illinois-based Baxter designed its new Novum IQ syringe infusion pump (SYR) to deliver small amounts of fluid at low rates. It includes a technologically integrated user experience with enhanced safety features. The system offers advanced connectivity, configurable anesthesia care settings and a set portfolio for optimum accuracy.

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

Baxter, The Links partner to raise kidney health awareness in Black communities

Baxter (NYSE:BAX) announced today that it expanded its partnership with The Links to improve awareness and resources related to kidney health.

An international not-for-profit organization, The Links will join Baxter to bring awareness to the disproportionate challenges affecting Black Americans related to kidney health.

Deerfield, Illinois-based Baxter is committing an incremental $800,000 in funding to The Links, specifically targeted toward expanding the program’s footprint to additional areas with a high prevalence of chronic kidney disease (CKD).

According to a news release, the latest $800,000 investment from Baxter brings the company’s cumulative contributions to The Links to $1.4 million over two years. Baxter and The Links joined forces in 2021 to create intervention-based programs focused on the prevention, detection, and management of CKD.

Baxter said that, during the inaugural program year in The Links Central region, 36 local cha…

BD wins patent lawsuit against Baxter over drug-transfer system

BD (NYSE:BD) picked up a legal victory in a patent spat with Baxter (NYSE:BAX) over a system for moving drugs.

A federal judge in Chicago ruled that BD’s PhaSeal system for transporting hazardous drugs between syringes and vials doesn’t infringe two patents belonging to Baxter.

U.S. District Judge Joan H. Lefkow granted BD summary judgment on two patent claims and resolved all claims in its favor. She denied BD’s motion for summary judgment on willfulness and damages as moot. She also denied Baxter’s motion for partial summary judgment as moot, terminating the case.

Baxter had alleged that the combination of two components of the PhaSeal system — the “protector” and “injector” — form a device that infringes on three of its patents, each entitled “Sliding Reconstitution Device With Seal.”

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

Baxter misses on revenue in Q2, cuts outlook amid ‘macroeconomic headwinds’

Baxter this morning (NYSE:BAX) reported mixed second-quarter results, with the medtech giant reducing its full-year outlook amid supply chain challenges and inflationary pressures.

BAX shares were down more than 6% to $62.44 apiece in pre-market trading.

The Deerfield, Ill.–based company — maker of renal care products, drug delivery devices and more — earned $252 million, or 50¢ per share, off $3.75 billion in sales for the quarter ended June 30, 2022, for a bottom-line slide of 15% and a top-line gain of 21%.

Adjusted to exclude one-time items, the company had EPS of 87¢, meeting the expectations of The Street, where analysts predicted an adjusted EPS of 87¢. Q2 revenues missed the analysts’ $3.88 billion projection.

“Baxter’s diverse, durable portfolio of essential healthcare products powers our business, even amid unprecedented macroeconomic headwinds,” Baxter CEO José (Joe) E. Almeida said in a news release.

“While we continue to …

Baxter recall of drug compounding software is Class I

The FDA issued a notice today announcing that the recall of the Baxter Abacus software is Class I, the most serious kind.

Baxter designed its Abacus order entry and calculation software to perform calculations for compounding liquid doses of medications. When connected to a compounded that mixes doses according to the calculation, the software can translate a physician’s order into a compounded solution ready to be given to a patient.

The company recalled the software application due to a risk that final printed bag labels for compounded mixtures may contain incorrect information, with the issue potentially occurring if a user unintentionally or incorrectly modifies a label template used to provide clinical care. Incorrect values or patient names on these labels may cause serious harm, especially if the wrong amounts or wrong medications are administered to high-risk patients. There have been five complaints, zero injuries and zero deaths related to the i…