CareFusion Recalls Alaris Pump 8100 Due to Software Delay Issue
CareFusion is recalling Alaris Pump model 8100 units with specific software versions because a defect may prevent the pump from properly delaying infusions.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a software defect that could lead to improper medication delivery. While no injuries or deaths are reported in the source text, the potential for harm to patients due to incorrect infusion timing places this in the 'High' severity category (risk-of-harm products where injury has not yet been reported).
Plain-English summary
CareFusion 303, Inc. is recalling the Alaris Pump model 8100 with software version 9.1.18 and associated software upgrade kits. The recall involves 57,219 units in total, with 55,756 units distributed in the United States. The affected products were distributed nationwide in the US as well as in Canada, the United Arab Emirates, Australia, and Kuwait.
The recall is being conducted because the pump may have a software issue that results in the module not properly delaying an infusion when the "Delay Until" option or "Multidose" feature is used. This defect could affect the timing of medication or fluid delivery to patients.
Healthcare facilities and users should check their Alaris Pump model 8100 units against the list of affected serial numbers provided in the official recall notice. If a unit is affected, users should follow the instructions provided by CareFusion to address the software issue.
The recalled product
- Product
- Alaris Pump model 8100 with software version 9.1.18 and software upgrade kits with "Delay Until" Option and "Multidose" Feature The Alaris Pump module is a large volume infusion pump offered under the Alaris System. The Alaris Pump module will deliver medication and fluids usi
- Manufacturer
- CareFusion 303, Inc.
- Category
- Medical Device — Infusion Pump
Distribution
Distributed nationwide across the United States.
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