The U.S. Dept. of Homeland Security (DHS) issued a medical advisory to warn of vulnerabilities with the Insulet (NSDQ:PODD) Omnipod insulin management system. According to the advisory, the affected insulin pumps are designed to communicate using a wireless RF with Insulet’s personal diabetes manager device, but the RF communication protocol does not properly implement authentication or […]
BD subsidiary CME recalls BodyGuard sets after reports of under-infusion
The FDA today said it is designating a recall of CME America BodyGuard microset infusion sets as Class I — it’s most serious level — after complaints of under-infusion related to the sets. CME America, a subsidiary of Becton Dickinson (NYSE:BDX), initiated the U.S. recall of the sets (catalog number A120-003XYVA) on Sept. 6, 2019, recalling […]
BD recalls hundreds of thousands of Alaris pumps due to multiple issues
The FDA today warned on a Class I recall of Becton Dickinson (NYSE:BDX) Alaris system infusion pumps due to multiple system errors, software errors, and use-related errors. All lots of five different models of the Alaris system were included in the recall that Becton Dickinson initiated on Feb. 4. In total, the company recalled 774,000 devices […]
BD warns on some ambulatory syringe pumps
Becton Dickinson (NYSE:BDX) issued a field safety notice in the United Kingdom to warn on an issue with its T34 and T34L (T60) ambulatory syringe pumps. The company was alerted to an issue with the syringe pumps that could cause risk of under-infusion and/or alarm failure, according to the notice published today. Get the full story at our […]
BD warns on some Alaris extension sets
Becton Dickinson (NYSE:BDX) issued an urgent field safety notice to warn customers in Europe of an issue with specific lots of its Alaris extension sets. Through customer feedback, the company found the potential for the male luer of the Alaris extension set to become disconnected from the female luer of the connecting device, both upon initial […]
FDA says Medtronic MiniMed insulin pump recall is serious
The U.S. FDA has designated a recall of hundreds of thousands of Medtronic Minimed insulin pumps as Class I — the most serious type of recall. Medtronic (NYSE:MDT) first warned of safety problems with the pumps in November. The recall involves 322,005 pumps — MiniMed 630G (model MMT-1715) and MiniMed 670G (model MMT-1780) — in the […]
Medtronic launches data management software program for Synchromed II
Medtronic (NYSE:MDT) this week launched a cloud-based data management software platform for its Synchromed II drug delivery system. The Efficio platform is designed to allow clinicians to manage targeted drug delivery pump practices to treat patients who have chronic pain, cancer pain and severe spasticity. It consolidates, organizes and provides visual summaries of patient data received […]
Indiana man may proceed with pain pump lawsuit against Medtronic
An Indiana federal judge on Friday dismissed two parts of a lawsuit against Medtronic (NYSE:MDT), but said that the plaintiff can continue to pursue the third count. Kirk Bledsoe sued Medtronic in Indiana state court in 2017 after the company’s Synchromed II pain pump, which Bledsoe had implanted in 2011, failed on two occasions and […]
Smiths Medical recalls Medfusion 4000 due to issue with software update
Smiths Medical has recalled its Medfusion 4000 syringe pump with Firmware version 1.7.0 due to malfunctioning alarms and potential interruption of therapy, FDA said today. The FDA has labeled the recall as Class I, it’s most serious designation. The Medfusion 4000 syringe pump is designed to deliver blood, blood products or prescribed drugs into a […]
Medtronic adds an AI Klue to its diabetes management lineup
Medtronic (NYSE:MDT) said today it has completed the acquisition of Klue, a San Jose, Calif.-based software company that tracks people’s eating in real-time and analyzes it with artificial intelligence (AI) to help control diabetes. Medtronic plans to incorporate Klue’s technology into its Personalized Closed Loop (PCL) insulin pump system, which won FDA breakthrough device designation in February. PCL is […]
B. Braun Medical names new chairman & CEO
B. Braun Medical has announced that Jean-Claude Dubacher will succeed longtime company leader Carroll Neubauer as chairman and CEO on Jan. 1, 2020. Neubauer will stay on as chairman and CEO of B. Braun of America, which owns B. Braun Medical (Bethlehem, Pa.), admixture pharmaceutical firm CAPS, Aesculap and B.Braun Interventional Systems. He has been […]
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