ICU Medical Plum Solo Precision IV Pump May Deliver Excess Medication
ICU Medical is recalling the Plum Solo Precision IV Pump (v1.0.3) because in specific scenarios, the pump may fail to decrease the displayed volume and could deliver up to twice the programmed medication amount.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 FDA classified this as a Class II recall involving an infusion pump that can deliver up to twice the intended medication dose. Although no illnesses or injuries are explicitly reported in the source text, the potential for serious patient harm from medication overdose and the Class II classification indicate this meets the Severe threshold per the rubric.
Plain-English summary
ICU Medical, Inc. is recalling the Plum Solo Precision IV Pump, version 1.0.3 (Item Number 400010401) due to a software defect that affects medication delivery accuracy.
In a specific scenario, the pump will not decrement the Volume to be Infused (VTBI) displayed on the Delivery screen and may deliver up to twice the VTBI at the programmed rate. This could result in patients receiving an overdose of medication.
The pump was distributed worldwide to the United States and Canada. A total of 5,059 units are affected, identified by UDI/DI +M335400011 and specific serial numbers listed in the FDA recall notice.
Hospitals and healthcare facilities using the affected Plum Solo Precision IV Pump should stop using them and contact ICU Medical, Inc. for instructions on how to obtain a replacement or software update to resolve the issue.
The recalled product
- Product
- ICU Medical Plum Solo Precision IV Pump, v1.0.3, Item Number 400010401; infusion pump
- Manufacturer
- ICU Medical, Inc.
- Category
- Medical Device — Infusion Pump
- Affected units
- 5,059
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 +M335400011
- Serial Numbers: 60000316
- 60000363
- 60000375
- 60000388
- 60000428
- 60000451
- 60000469
- 60000495
- 60000529
- 60000569
- 60000580
- 60000637
- 60000643
- 60000647
- 60000652
- 60000668
- 60000670
- 60000689
- 60000692
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by ICU Medical, 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 2 products in this recall →Related recalls
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