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| Alaris pump--Courtesy CareFusion |
CareFusion's ($CFN) Alaris pump is again the subject of a recall, earning the FDA's most serious designation over a software problem that can muddle scheduled infusions and put patients at risk.
The pump, designed to deliver medicines and fluids in a hospital setting, may fail to delay an infusion despite being programmed to do so, the company said, and the device is prone to missing multidose administrations depending on when they're inputted. The FDA designated the issue a Class I recall, reserved for device malfunctions that could lead to serious injury or death.
CareFusion first informed customers of the problem last month, promising to contact each individually to schedule a software installation that would remedy the issue. The company said it had not received any reports of adverse events tied to the software. The FDA asks customers to disclose any such problems through its MedWatch system.
The malfunction makes for CareFusion's fourth Alaris-related Class I recall in two years, following issues with the device's keyboard, peripheral attachments and power supply. In October, the San Diego company endured the agency's most serious designation over a problem with its AVEA ventilators, which tended to underreport volume on their neonatal setting.
CareFusion gets the majority of its revenue from infusion systems and respiratory technologies, part of a combined business that slipped 2% to bring in $571 million in sales last quarter. Overall, the company boosted its revenue 7% to $968 million in Q3 thanks to double-digit growth in its disposables segment.
- read the FDA's note
- here's CareFusion's letter to customers (PDF)