Another Class 1 Recall of CareFusion’s Alaris Pump

A problem with the keypad overlay could cause fluid ingress which could lead to a keypad malfunction causing the infusion to stop with alarm, an FDA notice in August said. When infusion stops, this could result in serious injury or death, it added.
A company letter to customers in July asked them to visually examine the pump module keypad overlay for obvious signs of overlay separation. It further informed them that the company will contact their facility by phone within 60 days to schedule a visit to replace the door assembly on their affected pump module.

Earlier in August, CareFusion recalled its Alaris PC unit model 8015 manufactured after January 2011. An FDA notice said that the PC unit, part of the Alaris electronic infusion pump, was recalled because a component on the PC unit power supply board is causing an error code accompanied by an audible alarm and a visual error message on the PC screen.

And last summer, a Class 1 recall involving this same pump involved a communication error that could occur under certain wireless conditions.

In 2010, FDA gave CareFusion permission to resume manufacturing its Alaris SE line of pumps. The company had been operating under a 2007 consent decree with FDA, which included an injunction against manufacturing and selling these pumps.

Company officials at the time said that while the work under the consent decree was not finished, they had made efforts to improve the quality system and to take steps necessary to resume production, sale, and installation of the pumps.