|The FDA warns that Hospira's GemStar infusion system can result in serious injury.--Courtesy of Hospira|
Hospira ($HSP) is warning customers of a dangerous battery malfunction with its GemStar infusion system, and the FDA has assigned its most serious label to the problem, warning that a resultant delay in delivery could cause serious injury or death.
Once the GemStar's battery drops below a certain charging level, it displays an error and is rendered inoperable, interrupting infusion and deleting settings and logs from the device's CPU, the company said.
Hospira issued a field correction in mid-March, asking customers to consider a different device for patients who could suffer severe reactions from delayed infusion, and, in the meantime, request replacement batteries for GemStar units.
The FDA assigned a Class I tag to the problem, reserved for malfunctions that can result in death, and the agency is asking patients and physicians to report adverse events through its online MedWatch platform.
The GemStar issue piles on to Hospira's long-running struggles with the FDA over infusion pumps. In November, the agency banned the company from importing its Symbiq infusion pumps, and Hospira said the action could strip $50 million to $100 million from annual sales if it stays in effect through 2013. Most recently, the FDA handed Hospira a Form 483 over how it manufactures pumps at its Illinois headquarters, starting a process that often ends with a full-scale warning letter.