ICU Medical Recalls Plum 360 Infusion Systems Due to Software Malfunction
ICU Medical is recalling 21,461 Plum 360 Infusion Systems because a software defect can prevent users from stopping the pump or restarting delivery under specific conditions.
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: The recall is classified as FDA Class II. The hazard involves a medical device malfunction that could prevent the user from stopping an infusion or restarting delivery, which poses a risk of harm, but the source text does not report any specific injuries or illnesses.
Plain-English summary
ICU Medical Inc is recalling 21,461 Plum 360 Infusion Systems, List number 30010. The recall involves devices equipped with software version v15.10.00.010. These devices were distributed nationwide to medical facilities, as well as to government and military entities, and were also distributed to Canada and Australia.
The recall is due to a software defect that can cause the pump to malfunction in two specific scenarios. First, if a malfunction alarm occurs while the pump is in the "Paused" state waiting for distal pressure to decrease, the pump cannot be turned off and delivery cannot be restarted until the battery is discharged or disconnected. Second, if a user accesses the Preventive Maintenance Screen in Service/Biomed Mode with a Total Delivery Time greater than 1,500 hours, the user will be unable to interact with the device, requiring a power cycle to restore function.
The source text does not report any specific injuries or illnesses associated with this defect. Medical facilities and users of these devices should contact ICU Medical Inc for instructions on how to address the software issue.
The recalled product
- Product
- Plum 360 Infusion System, List number 30010.
- Manufacturer
- ICU Medical Inc
- Category
- Medical Device — Infusion Pump
- Affected units
- 21,461
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 devices with software v15.10.00.010
Distribution
Distributed nationwide across the United States.
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