ICU Medical Plum Solos infusion pump may bypass maximum dose limit alert
ICU Medical Plum Solos infusion pumps with software version 1.1.1 may have a workflow that bypasses the Maximum Dose Limit alert, which prevents overdosing patients on weight or body surface area-based medications.
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: FDA Class II medical device recall for a potential software issue that could bypass medication dose safety alerts. No illnesses or injuries have been reported, but the hazard involves risk of medication overdose if the dose limit safety feature fails as described.
Plain-English summary
ICU Medical is recalling certain Plum Solos infusion pumps (Item number 400011001) due to a potential software issue. Internal testing identified a workflow in software version 1.1.1 that may bypass the Maximum Dose Limit alert, a critical safety feature within the LifeShield Medication Management Safety Software. The Maximum Dose Limit prevents the pump from delivering medication doses above a configured maximum for weight or body surface area (BSA) based medication dosing.
If this alert is bypassed, healthcare providers or patients could inadvertently program the pump to deliver medication doses exceeding the intended safety maximum, creating a risk of medication overdose.
The recall affects approximately 214 units distributed nationwide in Florida, Kentucky, Virginia, Mississippi, Massachusetts, Pennsylvania, New York, California, and Iowa, as well as internationally in the Philippines. Specific lot numbers are identified in the FDA recall notice.
Patients and healthcare facilities using affected Plum Solos units should contact ICU Medical immediately for instructions on obtaining a software update or replacement device.
The recalled product
- Product
- ICU Medical Plum Solos, Item number 400011001; 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)
- 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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