CareFusion Alaris Pump Module Model 8100 Recalled for Broken Platen Elements
CareFusion 303, Inc. is recalling Alaris Pump Module Model 8100 units because broken platen elements can cause inaccurate fluid delivery, leading to over-infusion, free-flow, or under-infusion.
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: "Broken elements on pump module platen such as broken upper hinge post, lower hinge, and membrane frame can occur when the door is forcefully closed on an object, the device is dropped, or if improper cleaners are used on the membrane frame…"
Plain-English summary
CareFusion 303, Inc. is recalling 1,093,588 units of the Alaris Pump Module Model 8100. The recall affects all serial numbers of the device. The product was distributed across all 50 U.S. states, the District of Columbia, and several U.S. territories, as well as numerous international locations including Canada, the United Kingdom, Germany, and Australia.
The recall is due to a risk that elements on the pump module platen, such as the upper hinge post, lower hinge, and membrane frame, may break. This damage can occur if the device door is forcefully closed on an object, if the device is dropped, or if improper cleaners are used on the membrane frame assembly. These broken elements may prevent the device from delivering accurate amounts of fluid.
Inaccurate fluid delivery may result in over-infusion, free-flow conditions, or under-infusion. The source text does not report any specific illnesses, injuries, or deaths associated with this recall.
The recalled product
- Product
- Alaris Pump Module Model 8100
- Manufacturer
- CareFusion 303, Inc.
- Category
- Medical Device — Infusion Pump
- Affected units
- 1,093,588
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 (1)
- All serial numbers
Distribution
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