|CareFusion is warning customers over problems with the PC unit of its Alaris infusion pump.--Courtesy of CareFusion|
CareFusion's ($CFN) Alaris infusion pumps are back in the FDA's sights, as the agency has assigned its most serious warning to the company's latest malfunction, saying the problem could lead to serious injury or death.
For the third time in a year, CareFusion has endured the FDA's Class I tag related to a recall of its Alaris PC unit model 8015, the on-board system that regulates the infusion pump. This time, CareFusion is warning that some models shipped with lower voltages than needed, risking a failure of communication between the processor and keyboard. If that happens, the Alaris unit could suspend infusion, putting patients in danger, the company said.
CareFusion wants customers who encounter the malfunction to contact the company and schedule an inspection and repair, and the FDA is asking patients and physicians to report any adverse events through its MedWatch system.
In March, CareFusion warned of a similar problem with the same device, cautioning customers that the use of certain attachments could lead to the keyboard being rendered unresponsive until the pump could be restarted. In August, the company warned about the same device's power supply, saying it could malfunction and interrupt infusion. The FDA applied its Class I tag to both problems.
The San Diego devicemaker gets most of its revenue from medical systems, a business that slipped 6% to $584 million last quarter. Dispensing technologies dropped 10% to $234 million while infusion systems stayed flat at $246 million. Total revenue slipped 2% to $901 million on the quarter, while net income fell about 3.8% to $84 million.
CareFusion will report its fiscal third quarter results after markets close Thursday.
- read the FDA's note