Class I Recall for CareFusion Alaris Infusion Pump

Class I Recall for CareFusion Alaris Infusion PumpMay 21, 2014 — CareFusion is recalling the Alaris infusion pump, model 8100, version 9.1.18, because a software problem may delay an infusion or improperly deliver a multi-dose infusion. Infusions that start earlier or later than intended could cause serious injury or death.

The Alaris Pump Model 8100 is a large-volume infusion pump that is intended for use in a healthcare facility. It is designed to deliver fluids, medicines, blood, and blood products using continuous or intermittent delivery through various routes, including under the skin.

According to the recall from the U.S. Food and Drug Administration (FDA),

“It may have a software failure where the pump module will not properly delay an infusion when the “Delay Until” option or “Multidose” feature is used.  The firm received one report where the device malfunctioned when the “Delay Until” option was selected. The software failure also causes the pump to not properly deliver a multidose infusion as expected.”

CareFusion informed customers of the recall on April 23, 2014. The company recommends that customers should NOT use the Alaris Pump module “Delay Until” option or the “Multidose” option. Instead, they recommended that the previous Alaris Pump module software version 9.1.17 be installed to address this recall. Customers can contact CareFusion to schedule installation of the software.

In August 2012, the CareFusion Alaris 8100 was recalled because the keypad covering could loosen or peel away, which might allow fluid to enter the device and cause a malfunction.

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