Damaged IUI connectors may lead to interruption of communication or power between PC Unit and modules, which could result in an infusion that stops with an alarm on the PC Unit and an interruption of therapy or monitoring.

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A broken upper hinge post, lower hinge, and/or membrane frame on the Alaris™ pump module may prevent the device from delivering an accurate amount of fluid, which may result in an over infusion, free-flow conditions, or under infusion without an alarm.

"Becton Dickinson (BD) CareFusion 303 Recalls Alaris System Infusion Pumps Due to Damaged Inter-Unit Interface Connectors, Loose or Missing Battery Screws and A Broken Upper and Lower Hinge Posts and Membrane Frame" FDA (2020).

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The LED display on the module may have some segments that appear dim, and therefore, the number may not be clearly displayed. The purpose of this display is to provide the clinicians with infusion or patient monitoring values associated with the type of module. If this dim segment is discovered during clinical use, it may cause slight user confusion or inconvenience when noticed.

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Use of these devices may cause serious injuries or death. The FDA has identified the occurrence of Situation 4 as a Class II recall and use of these devices may cause temporary or medically reversible injury.

If the battery is not properly secured to the Alaris™ PC Unit that is running on battery power, the system may experience a power loss with a prolonged, non-silenceable alarm. Power loss may result in an interruption of patient therapy or monitoring.

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