[pending] ICU Medical Plum Solos, Item number 400011001; infusion pump
Pending LLM rewrite. Source: FDA_DEVICE Z-1991-2025.
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: Pending LLM scoring against the rubric.
Plain-English summary
Internal testing found that Plum Duo pumps with software version 1.1.1 have a workflow that may result in bypassing the Maximum Dose Limit alert. The Maximum Dose Limit is set in the LifeShield Drug Library Manager (DLM) within the LifeShield Medication Management Safety Software and specifies the highest dose at which the pump can be programmed for weight or BSA (body surface area) based medication rulesets. The limit can be configured for Dose, Loading Dose, and Bolus Dose.
The recalled product
- Product
- ICU Medical Plum Solos, Item number 400011001; infusion pump
- Manufacturer
- ICU Medical, Inc.
- Category
- Medical Device — Devices
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 (20)
- UDI/DI N/A
- Serial/Lot Numbers: 60000001
- 60000002
- 60000003
- 60000005
- 60000006
- 60000007
- 60000008
- 60000009
- 60000010
- 60000011
- 60000014
- 60000015
- 60000016
- 60000017
- 60000019
- 60000020
- 60000021
- 60000023
- 60000024
Distribution
Distributed nationwide across the United States.
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