CareFusion Hit with Another Serious Infusion Pump Recall

FDA has given Class I status to a Carefusion recall related to the Alaris Model 8100 infusion pump. A software failure in the pump had been identified in modules running software version 9.1.18. Last June, the related Model 8015 PC unit had its own recall. 

This is the 10th Class I recall designation that CareFusion has received since the beginning of 2012. Only Johnson & Johnson has had as many serious recalls during that time period.

According to the FDA notification, the Alaris Model 8100 is a large-volume infusion pump "intended for use in health care facilities that use infusion for the delivery of fluids, medicines, blood, and blood products using continuous or periodic (intermittent) delivery through various routes such as under the skin."

The affected products were manufactured from February 6, 2014, to April 8, 2014, and distributed from February 7, 2014, through April 7, 2014. Serial numbers of the affected units are listed in a PDF.

In a customer letter letter dated April 23, Chuck Donion, vice president, quality and regulatory affairs, infusion technologies, wrote that the San Diego-based company had "identified a software issue with the Alaris pump that results in a situation where the pump module will not properly delay an Infusion when the 'delay until' option or 'multidose' feature is used."

"Although no adverse events or deaths have been reported," the letter says, "if the infusion starts earlier or later than intended and is not immediately detected and stopped by the clinician this could result in serious injury or death." The company says this issue does not impact the "delay for" option, nor does it impact the Alaris Syringe Module "delay until" option or "multidose" features.

CareFusion says that it has identified the root cause of this issue and the company recommends that the previous Alaris pump module software version 9.1.17 be installed to resolve this issue. CareFusion says that it is contacting all affected customers to schedule the software installation.

As an interim measure, CareFusion advises that "customers may update their dataset to disable both "delay options" and/or "multidose" across all profiles to prevent the use of 'delay until' option and/or 'multidose' feature." It cautions,, however, that these "are shared configurations with the Alaris Syringe module and if disabled would prevent use of these features with the Alaris Syringe module as well."

CareFusion has also devoted a page on its website to the issue that includes links to a list of FAQs and a Tip Sheet.

Stephen Levy is a contributor to Qmed and MPMN.