The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-1567-2014·Announced 2014-05-21

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.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "CareFusion is recalling the Alaris Pump model 8100 version 9.1.18 because it may have a software issue that results in situation where the pump module will not properly delay an infusion when the "Delay Until" option or "Multidose" feature…"

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…
Manufacturer
CareFusion 303, Inc.
Category
Medical Device — Infusion Pump
Hazard

Distribution

Distributed nationwide across the United States.

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