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 patient’s […]
Smiths Medical, United Therapeutics conspired to stifle generic Remodulin, Sandoz alleges
Smiths Medical allegedly conspired with United Therapeutics to stifle a generic version of pulmonary arterial hypertension drug Remodulin, according to a lawsuit filed this week by Novartis (NYSE:NVS) unit Sandoz. The Smiths Group (LON:SMIN) subsidiary, which is slated for a spinout as a separately traded company next year, makes the infusion pumps and single-use cartridges for […]
Smiths Medical spikes merger talks with ICU Medical
Smiths Group (LON:SMIN) said yesterday that it’s spiking merger talks with ICU Medical (NSDQ:ICUI) after rejecting a nearly $4 billion offer earlier this month. The British company and San Clemente, Calif.-based ICU revealed negotiations in May about a possible union with Smiths Medical. Smiths, said to be eyeing the exit door last month, reportedly rejected a cash-and-stock offer […]
Smiths Medical inks distro deal for infusion therapy products
Smiths Medical plans to distribute its CADD infusion systems to non-hospital-based providers through a preferred partnership with Medical Specialties Distributors, the company reported today. As part of its new distribution model, Smiths will also make its infusion pumps and sets available to providers outside of the hospital setting through InfuSystem (NYSE:INFU) and Integrated Medical Systems. The […]
Smiths updates recall for Medfusion syringe pumps
Smiths Medical has amended an urgent medical device recall that it first issued in August for its Medfusion syringe pump model series 3500 and 4000. After acknowledging that a defect in certain models of the pump can cause an “invalid syringe size” alarm to go off, the company added an option for facilities with trained […]
US DHS warns of vulnerabilities in Smiths Medical Medfusion 4000 infusion pump
The US Dept. of Homeland Security’s Industrial Control Systems Cyber Emergency Response Team has released a warning over issues with Smiths Medical’s Medfusion 4000 wireless syringe infusion pump after discovering 8 cybersecurity vulnerabilities in the device. The notice is for versions 1.1, 1.5 and 1.6 Medfusion 4000 wireless syringe infusion pumps, according to the DHS […]
Smiths Medical wins 510(k) approval for wireless ambulatory infusion pump
Smiths Medical said yesterday that it won 510(k) clearance from the FDA for its CADD-Solis wireless ambulatory infusion pump. The device can connect wirelessly with Smiths’ PharmGuard Server infusion management software, enabling clinicians to deploy updates and drug libraries to all pumps simultaneously, as well as remotely manage device performance and monitor drug dosing. The […]
Smiths Medical debuts drug pump software
Smiths Group (LON:SMIN) Smiths Medical division today launched an updated version of its PharmGuard interoperability software for its Medfusion 4000 wireless syringe pumps. The new version features bi-directional integration with any IHE compatible electronic medical record system, the company said. Smart pump programming allows a clinician order to be sent directly to the Medfusion pump, […]
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