|Hospira's GemStar pump is the subject of another Class I recall.--Courtesy of Hospira|
Hospira's ($HSP) long-troubled infusion pump business is dealing with another recall, earning the FDA's most severe warning over a device malfunction the agency said can lead to serious injury and death.
At issue are 5 models of Hospira's GemStar Infusion System. The FDA said the devices' pressure sensors have a tendency to drift, leading to errors that can shut down the pump and put patients at risk. Furthermore, the problem can lead to undetected fluid blockages, which, once resolved, can result in dangerous over-infusion.
Hospira first warned customers of the problem in March, advising them to run tests for infusion obstructions and, if their devices fail, to take them out of service and send them back. In the meantime, the company is modifying GemStar's manual to include an annual requirement for such tests.
This week, the FDA labeled the effort a Class I recall, which it reserves for device malfunctions that carry a reasonable probability of injury or death. The agency is asking patients and physicians to report any adverse events tied to GemStar through its MedWatch system. In April, GemStar endured a Class I tied to a battery malfunction.
The latest recall adds to a lengthy list of pump-related woes for Hospira, and the company is working to turn the page on its years-long regulatory troubles. In May, Hospira unveiled its "device strategy," a plan that involves gradually retiring old pumps like the oft-recalled GemStar and FDA-blocked Symbiq, replacing them with the Plum A+ and Sapphire systems. In tandem, Hospira said it's investing in the development of new technologies and stronger quality systems, planning to roll out new devices and adopt stricter manufacturing standards.
Those reforms will dampen full-year revenue by between 2% and 4%, the company said, and Hospira expects its annual sales to slip between 3% and 5% in 2013. Last quarter, net revenue ticked upward 1.4% to about $1 billion, but slumping device sales weighed down growth in pharmaceuticals thanks to "the impact of the ship-hold of most of the company's infusion devices previously put in place due to prior actions of various regulatory authorities," the company said.
- read the FDA's note