Plum Duo infusion pump software vulnerability bypasses maximum dose limit
ICU Medical Plum Duo infusion pumps with software version 1.1.1 contain a vulnerability that may bypass the Maximum Dose Limit safety alert. A total of 1,701 affected units have been distributed worldwide.
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: This recall is classified as Score 3 (High) as a risk-of-harm medical device with no reported illnesses or injuries to date. The software vulnerability affecting the critical Maximum Dose Limit safety feature in an infusion pump poses significant potential for patient harm.
Plain-English summary
ICU Medical is recalling Plum Duo infusion pumps (item numbers 400020401, 400021001, and 400021003) due to a software vulnerability. Internal testing identified a workflow in software version 1.1.1 that may bypass the Maximum Dose Limit alert, which is a critical safety feature that prevents the pump from delivering doses above the configured maximum based on patient weight or body surface area.
The affected units total 1,701 and have been distributed worldwide, including to facilities in Florida, Kentucky, Virginia, Mississippi, Massachusetts, Pennsylvania, New York, California, Iowa, and the Philippines. This vulnerability could potentially allow medication overdose if the safety limit bypass occurs.
Healthcare facilities using affected Plum Duo pumps should discontinue use of units matching the specified lot numbers and contact ICU Medical for device replacement or software updates.
The recalled product
- Product
- ICU Medical Plum Duo, Item numbers: 1) 400020401, 2) 400021001 , and 3) 400021003; infusion pump
- Manufacturer
- ICU Medical, Inc.
- Category
- Medical Device — Infusion pump
- Hazard
- dose-limit-bypass
- overdose-risk
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)
- 1) 400020401: UDI/DI 400020401
- Serial/Lot Numbers: 50000184
- UDI/DI +M335400021
- Serial/Lot Numbers: 50002748
- 50002774
- 50001647
- 50001654
- 50001601
- 50001615
- 50001651
- 50002547
- 50002577
- 50002678
- 50002689
- 50002750
- 50002751
- 50002755
- 50002773
- 50002788
- 50002798
Distribution
Distributed nationwide across the United States.
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