Latest CareFusion Alaris-related Recalls Are Class I

Infusion pumps have been one of the most recall-plagued medical device types of the past decade.

Nancy Crotti

FDA has assigned a Class I designation to a recall of CareFusion Alaris infusion pumps, originally announced last month.

The agency gave the same designation to a recall of frame membranes that Elite Biomedical Solutions makes for Alaris pumps.

The CareFusion recall involves 6,458 Alaris Syringe Pumps, Model No. 8110, manufactured and distributed from March to September 2014, according to the FDA recall notice.

An error in the syringe pump triggers a visual and audible alarm and causes the pump to stop working, according to the notice. Even when the user clears the error code, the syringe pump does not respond until the product is detached and reattached to the PC unit used to program, monitor, and provide power to the syringe pump, the agency said. Failure of the syringe module may result in a delay or interruption of therapy and can lead to serious patient injury or death, it added.

CareFusion (San Diego, CA), which is now part of BD, has received 108 reports of the issue occurring, FDA said. There have been no reports of permanent injury or death.

CareFusion spokesperson Troy Fitzpatrick said that the company has contacted all affected customers to "initiate the scheduling process for the remediation.

"To remediate the pumps, we will adjust the syringe drive train assembly on the affected units and replace, if required."

The company listed all affected serial numbers on its website.

FDA issued a separate recall announcement related to Elite Biomedical and the Alaris Medley Large Volume Pump, an infusion pump used to deliver liquid nutrients and medications in controlled amounts. The frame membranes that Elite makes for the pumps are designed to prevent fluids from leaking into the pump's internal components.

According to notice, Elite Biomedical (Cincinnati) discovered that the use of this part could result in over- or under-infusion of fluids, with the potential to cause patient injury or death.

The 1502 recalled devices were manufactured from February 20 to April 21, 2015, and distributed from February 25 to May 8.

Elite Biomedical began sending customers product advisory notices in May, followed by urgent recall letters and a press release to all U.S. hospitals in June.

"We are working to get the recalled frames out of the marketplace," said Brenda Compliment, a quality engineer with Elite Biomedical. "We have identified the root cause and we have corrective actions in place to prevent this moving forward."

Infusion pumps have been one of the most recall-plagued medical devices in the past decade. From 2005 through 2009, FDA received roughly 56,000 reports of adverse events linked to infusion pumps. In that timeframe, 87 infusion pumps were recalled in the United States for safety reasons.

Earlier this summer, FDA raised the alarm over Hospira infusion systems with hacking vulnerabilities. Hospira, which Pfizer is in the process of acquiring for $17 billion, has had seven Class I-level infusion pump recalls since the start of 2013, according to the FDA's medical device recall lists. Five have involved the GemStar Infusion System, which has been plagued with problems ranging from leaking batteries to pressure sensor calibration.

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Nancy Crotti is a contributor to Qmed and MPMN.