Field Safety Notice
BD is initiating an advisory Field Action for the BD Alaris TM Infusion Pump System concerning four hardware situations that require attention and actions.
Situations:
Situation 1: Damaged Inter-Unit Interface (IUI) Connectors may lead to interruption of communication or power between PC Unit and modules, potentially causing serious injury or death.
Situation 2: Broken elements on Alaris TM Pump Module platen may prevent the device from delivering an accurate amount of fluid, resulting in over infusion, free-flow conditions, or under infusion, potentially causing serious injury or death.
Situation 3: Improperly secured PC unit Battery may cause power loss with prolonged, non-silenceable alarm, potentially causing serious injury or death.
Situation 4: Dim Segment on the LED display may cause slight user confusion or inconvenience when noticed.
Customer Actions:
Inspect devices for the above issues, take affected devices out of service, and contact local BD representative or distributor for replacement parts.
BD Actions:
Providing updated Instructions for Use, Warnings, and Cautions, as well as accessory kits and an expanded Alaris TM Medication Safety program to support implementation of updated processes.
Manual:
Download: BD Alaris TM Infusion Pump System Field Safety Notice
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