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| CareFusion is recalling the PC unit of its Alaris infusion pump.--Courtesy of CareFusion |
CareFusion ($CFN) was plagued by regulatory problems all last summer, and now the company is reporting an issue with another model of its Alaris infusion pumps, earning the FDA's most-serious warning.
The devicemaker launched a recall of the Alaris model 8015 last month, warning of a communication error between the device's CPU and its attachments that can render the keypad unresponsive. When that happens, programmed infusions will persist, but restarting the device could put patients at serious risk, CareFusion said.
This week, the FDA assigned a Class I tag to the recall, a designation reserved for problems that could result in severe adverse events including death. The agency asks physicians and patients to report problems with the device through its online MedWatch system.
CareFusion isn't asking customers to send the devices back in, instead having representatives schedule software updates for the affected technology.
This isn't CareFusion's first spot of trouble with the model 8015: In August, the company endured a Class I recall of the device's power supply, warning that it could malfunction and interrupt infusion. The same month, CareFusion received a Class I tag over its recall of Alaris model 8100, warning that protective keypad overlay on the pump's door could come loose, exposing the keys to liquids and risking shutdown.
- read the FDA's announcement
- here's CareFusion's letter to customers (PDF)