Latest FDA Letter EXPANDs prohibition of pumps into USA beyond Symbiqs to include Plums, Gemstars, and LifeCare PCAs! Hospira's preliminary estimate is that the impact for this matter could be in the range of $50M-$100M in decreased net sales! Hospira withdraws 2013 guidance after FDA expands Symbiq alert Theflyonthewall.com - Feb 14, 2013 Hospira (HSP) disclosed in a regulatory filing that the company is withdrawing the 2013 full-year financial projections communicated during its earnings call on February 13 after it received written notification from the U.S. Food and Drug Administration that the FDA had expanded the Symbiq import alert issued on November 8, 2012. That alert prohibited the importation of Symbiq infusion pumps into the U.S. And the expansion received on February 13 prohibits the importation into the U.S. Of the Plum, GemStar, and LifeCare PCA infusion pumps which are manufactured in its Costa Rica facility, the company said.

The FDA’s import alert does not restrict importation of the Company’s consumables and other infusion pump accessories. Assuming that the import ban on Plum, GemStar, and LifeCare PCA remains in effect throughout 2013, the company’s preliminary estimate is that the impact for this matter could be in the range of $50M-$100M in decreased net sales and 10c-20c reduction in U.S. GAAP earnings per share or an adjusted earnings per share impact of 5c-15c.

The company said it will be refining these estimates, aggressively evaluating potential mitigation strategies, and plans on issuing new guidance at its Q1 earnings call. Click to expand.Morgan Hill has been closed for at least a year. Most of the production workers are gone.

There are probably some still in the San Jose U.S. Service Center, but they only fix the pumps that are customer returns. At Morgan Hill, the production workers met and exceeded the quota by 170%, and there was never a recall due to manufacturing quality (there was once a recall for electrical cords, but that was a supplier problem). Some of the problems, though, may be unrelated to manufacturing. Ireland makes very few pumps and only for the International market. Two big problems exist that need to be addressed.

First the total MMS operations business was managed from the Mt View/ Morgan Hill facility going back to 1986. Most of the legacy products have a strong proven platform however the design margin is not what you'd like to have. Knew how to manage the business while addressing issues that occur when devices stay out in the field for 20 plus years. The new folks on-board now out of Chicago have very little understanding of the legacy business and you can see the impact. Secondly and something Mike Ball needs to take responsibility for is the re-launch of the Symbiq. This product either needs to be totally scrapped or some major software work needs to take place.

Unfortunately a significant amount of development $$ have been spent on a product that may never have a positive ROI. Lastly many of the individuals making the decisions going forward for MMS are ex-Baxter employees. Baxter had some serious problems with their own business regarding the Colleague. Go back and you will find the Baxter had the same issues Hospira did and could not ship product in the US. What saved their business is the acquisition of Sigma.

Mike Ball needs to figure this out quick or the outcome won't be pretty. Ireland makes very few pumps and only for the International market.

Global repair rate. The Sapphire infusion system provides the performance. All through a single infusion pump.

Two big problems exist that need to be addressed. First the total MMS operations business was managed from the Mt View/ Morgan Hill facility going back to 1986. Most of the legacy products have a strong proven platform however the design margin is not what you'd like to have. Knew how to manage the business while addressing issues that occur when devices stay out in the field for 20 plus years. The new folks on-board now out of Chicago have very little understanding of the legacy business and you can see the impact. Secondly and something Mike Ball needs to take responsibility for is the re-launch of the Symbiq.

This product either needs to be totally scrapped or some major software work needs to take place. Unfortunately a significant amount of development $$ have been spent on a product that may never have a positive ROI. Lastly many of the individuals making the decisions going forward for MMS are ex-Baxter employees. Baxter had some serious problems with their own business regarding the Colleague. Go back and you will find the Baxter had the same issues Hospira did and could not ship product in the US. What saved their business is the acquisition of Sigma.

Mike Ball needs to figure this out quick or the outcome won't be pretty. Click to expand. That new alliance with Q Core Medical just announced may be the Sigma 'solution' to fix all their pump problems with a newer competitive product with smart pump safety features. My guess is that Hospira needs to streamline all their devices under a new umbrella with Q Core, as Gemstar never fit in the MedNet big picture anyway, and the current pump technology is antiquated and bulky, and the software and hardware appears unfixable at a reasonable cost. The brand is badly burned at this point. There were rumors of a repackaged Symbiq/Plum device, with a new name, new software, and new hardware, but that route seems stupid now. It's broken and it can't be fixed.

I am sure former Baxter personnel have no regrets going with Sigma, as it was impossible to fix the Colleague after all those FDA recalls. Hospira is best to follow suit with adaption of Q Core Sapphire multi-purpose smart pump as new lead technology. Hospira and Q Core Medical Sign International Distribution Agreement for Sapphire Infusion System LAKE FOREST, Ill., and PETACH TIKVA, Israel, Jan. 22, 2013 /PRNewswire/ -- Hospira, Inc. (NYSE: HSP), the world's leading provider of injectable drugs and infusion technologies, and Q Core Medical, Ltd., an innovation leader in infusion delivery systems, today announced that the companies have entered into a distribution agreement for the Q Core Sapphire™ multi-therapy infusion system.

Through the arrangement, Hospira will have exclusive rights to market and distribute Sapphire -- a compact and lightweight infusion device system frequently used in ambulatory and hospital settings -- in more than 60 key markets across Europe, Asia and The Americas. The agreement also enables Hospira to collaborate with Q Core for distribution of its product development pipeline. (Photo - ) 'Collaborating with Q Core reinforces Hospira's commitment to providing advanced infusion systems that help improve the safety and efficiency of I.V.

(intravenous) medication administration,' said Julie Sawyer Montgomery, vice president, Medication Management Systems Marketing, Hospira. 'With clinicians in multiple regions using the Sapphire system to support their medication administration needs, the device expands Hospira's ability to help support patient safety in key geographies.'

The Sapphire system satisfies a wide range of critical drug delivery needs in ambulatory and hospital care environments and readily adapts to emerging needs. It features a full-color touch-screen and software designed to enable intuitive programming and operation with minimal steps. The smart pump capabilities of the Sapphire system help healthcare organizations support a high level of medication delivery safety. The device is already in use in Canada and Europe, and under regulatory review for registrations in additional countries, including the United States.

'We see great synergy between our companies, combining our advanced technology with Hospira's superb customer support, technology, and global reach,' said Dr. Boaz Eitan, CEO of Q Core Medical.

'We believe that the addition of our Sapphire brand into Hospira's portfolio marks the beginning of a long-term and fruitful cooperation.' Adding the Sapphire system to the Hospira product portfolio strengthens the breadth of the company's already comprehensive medication management business. Hospira's current portfolio features products such as Plum A+™ with Hospira MedNet™ safety software, a proven and scalable advanced infusion pump system; Symbiq™ infusion system with built-in Hospira MedNet, the first general infusion system to require selection of an entry from the safety software for all drug delivery programs; the market-leading LifeCare PCA™ pain management pump with Hospira MedNet; and the GemStar™ ambulatory infusion device. KLAS recognized Hospira as the early leader in smart pump/EHR (electronic health record) integration, with more live I.V. Kitab Ul Mufradat Free Pdf there. Clinical integration sites than any other infusion pump provider and the only vendor to integrate with multiple EHR providers.1 Financial details of the agreement were not disclosed. About Hospira Hospira, Inc. Is the world's leading provider of injectable drugs and infusion technologies.

Through its broad, integrated portfolio, Hospira is uniquely positioned to Advance Wellness™ by improving patient and caregiver safety while reducing healthcare costs. The company is headquartered in Lake Forest, Ill., and has approximately 15,000 employees.

About Q Core Medical Q Core Medical is a dynamic, expanding medical devices company focused on the ambulatory and hospital based electronic infusion pump market. Q Core Medical designs, develops, manufactures, and markets advanced pump systems with multi-treatment I.V., enteral feeding, and veterinary capabilities. Our world-class scientists and engineers are committed to continuous research and development of new and progressive products and technologies. Visit Q Core online. Ireland makes very few pumps and only for the International market.

Two big problems exist that need to be addressed. First the total MMS operations business was managed from the Mt View/ Morgan Hill facility going back to 1986. Most of the legacy products have a strong proven platform however the design margin is not what you'd like to have. Knew how to manage the business while addressing issues that occur when devices stay out in the field for 20 plus years. The new folks on-board now out of Chicago have very little understanding of the legacy business and you can see the impact.

Secondly and something Mike Ball needs to take responsibility for is the re-launch of the Symbiq. This product either needs to be totally scrapped or some major software work needs to take place. Unfortunately a significant amount of development $$ have been spent on a product that may never have a positive ROI. Lastly many of the individuals making the decisions going forward for MMS are ex-Baxter employees. Baxter had some serious problems with their own business regarding the Colleague.

Go back and you will find the Baxter had the same issues Hospira did and could not ship product in the US. What saved their business is the acquisition of Sigma. Mike Ball needs to figure this out quick or the outcome won't be pretty. Click to expand.I agree with your assessment, but just want to add that the current challenge might also be related to life cycle issues. Except for Symbiq, all of the pumps were designed in the last millenium. It is difficult to find parts and it is possible these are in a constant state of redesign to substitute in newer components.

(Symbiq, even though everyone thinks it is a new pump, has been around since 2007.) Life cycle issues are a lot easier to deal with if the original designers were still around, but given the volatility of the workforce, this is highly unlikely.