Can you imagine?

Fluidnet is interviewed by Gray Sheet reporter Jessica Bylander about it's innovative work to solve the many challenges associated with IV infusion pumps:

November 22, 2010

Another Wrinkle For Baxter's Infusion Biz? Sigma Recalls Spectrum Pumps

Medina, N.Y.-based Sigma is recalling nearly a quarter of its Spectrum infusion pumps because the units may fail suddenly, resulting in potential over-infusion or other flow problems.

The malfunction, caused by the mechanical failure of a bearing within the pump assembly, could result in serious injury or death, according to the company and FDA, who classified the recall as Class I, the most serious category, Nov. 12.

Sigma has received 10 reports of Spectrum pump failures, but no reports of patient deaths or serious injuries. The company has asked customers to return affected units – those made between October 2006 and March 2008 - for servicing or replacement.

The recall is an unfortunate development not only for Sigma, but for Baxter, which distributes Spectrum pumps and is a minority owner of Sigma. Earlier this year Baxter was ordered by FDA to remove all of its Colleague infusion pumps from the U.S. market and to offer customers either a refund or a replacement pump: the Sigma Spectrum. (See " FDA Recall Order Gives Baxter Two Years To Replace Infusion Pumps " - "The Gray Sheet" July 19, 2010.)

Sigma says its newer pumps are made with an improved manufacturing process to prevent the bearing problem. And both Sigma and Baxter say the recall will not slow production timelines or delay the fulfillment of orders for new Spectrum pumps.

"The correction will be handled by Sigma's service technicians and is not expected to interfere with either the production of new devices or Baxter’s ability to transition current Colleague customers to Spectrum pumps," Baxter spokesman John O’Malley said.

But Morgan Stanley analyst David Lewis warned of possible repercussions.

"The recall puts Sigma in a negative light just as former Colleague customers are deciding whether to stay with Baxter/Sigma or to defect to a competitor," Lewis wrote in a Nov. 12 note.

The recall could provide an incremental bump to competitors CareFusion and Hospira, he suggested.

Pump maker B. Braun, which touts its "smart pump" technology to reduce medication-related adverse events, could also stand to benefit.

But some say the latest recall only underscores the need for a paradigm shift in infusion pump design (see sidebar).

Replacement Process To Take About A Year

Sigma alerted customers Sept. 14 that it was recalling 17,568 Spectrum pumps, representing more than 23% of the 75,000-plus Spectrum pumps in distribution.

The pump does not issue an alarm when failure occurs, nor is there any method for determining a unit's susceptibility for failure, according to the firm.

Repairs on returned pumps began Sept. 21. The firm expects to complete the recall and replacement process by the third quarter of 2011.

Smarter Smart Pumps?

So-called "smart pumps" are equipped with safety features, such as user alerts that activate when there is a risk of an adverse drug interaction or when the user sets the pump's parameters outside of specified safety limits.

Most of the major infusion pump players offer smart-pump products to reduce medication-related adverse events. Sigma's Spectrum line also contains such technology. But as the recall demonstrates, these next-gen pumps are not failsafe.

Start-up firm Fluidnet claims it has a solution to traditional infusion pump safety problems.

"If you really look at where these recall problems are coming from, it has nothing to do with the smart pump functionality," says Brent Nibarger, VP-business development, at Amesbury, Mass., start-up Fluidnet. "It has to do with electromechanical, software, power management and other components."

FDA's recently launched infusion pump improvement initiative aims to address common pump problems through better user interfaces and risk mitigation.

But Nibarger says the real fixes won't come without a fundamental change in pump design. "The core mechanics of the pump, the actual pumping mechanism, has not changed since 1975," he said.

Fluidnet is in late-stage development on a new type of infusion system that runs on pneumatic pressure, which involves using positive and negative air pressure to move the infused drug through the tubing.

The closed-loop system will measure the amount of medication delivered and compare that to a known reference standard "to actually measure what you're doing in real time," Nibarger explained, which could reduce risks such as over-infusion.

The system features optical flow sensing, flow and volume sensing technology within the pump, and a proprietary Biomed Inside technology that tests and calibrates the pump in real time, the firm says.

The product has only three internal moving parts, reducing risks such as mechanical failure, and actively eliminates air from the IV tube, Fluidnet notes. The firm anticipates first human use next year.

By Jessica Bylander