The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-1360-2020·Announced 2020-03-11

CareFusion Alaris Pump Module Recalled for Software Errors

CareFusion 303, Inc. is recalling Alaris Pump Module Model 8100 units due to software errors that may cause infusion interruptions or incorrect medication concentrations.

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: "1)Error 255-XX-XXX results in inability to edit settings 2)Delay options programming may result in no KVO rate/therapy interruption 3)Software errors results in no low battery alarm/infusion stopping 4)Medium priority KVO/End of Infusion…"

Plain-English summary

CareFusion 303, Inc. is recalling CareFusion Alaris Pump Module, Model 8100 units. The recall involves approximately 1,286,898 units distributed nationwide in the United States and internationally to Canada, Australia, New Zealand, and other regions. The affected units are equipped with software versions 12.1.0, and 9.33 and prior.

The recall is due to software errors that may result in the inability to edit settings, infusion interruptions, failure of low battery alarms, unrecognized infusion completion, and incorrect medication concentrations. These errors could lead to therapy interruptions or administration of medication at concentrations lower or higher than ordered.

Healthcare facilities and users should contact CareFusion 303, Inc. for instructions on how to address the software issues. The source text does not specify a specific action for consumers, as the product is a medical device used in clinical settings.

The recalled product

Product
CareFusion Alaris Pump Module, Model 8100
Manufacturer
CareFusion 303, Inc.
Category
Medical Device — Infusion Pump
Hazard
Affected units
1,286,898

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Software versions 12.1.0
  • and 9.33 and prior

Distribution

Distributed nationwide across the United States.

The notice also names 55 states specifically:

Part of a larger recall action

This product is one of 4 recalled by CareFusion 303, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

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