# K161469: Plum 360(TM) Infusion System with MedNet/ Smart Card Plug and Play Module

- Pathway: 510(k) (Traditional)
- Applicant: Hospira, Inc.
- Decided: Mar 28, 2017 after 305 days
- Product code: FRN (Pump, Infusion)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: 6 (2 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K011442 (2001). 25 ancestors in all.
5 later devices descend from it; 2 cite it directly.
11 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141789: Plum 360 Infusion System with Hospira Mednet, Smart Card Plug N Play CE 3.0 Module for Plum a+ Infusion System Upgrade, Hospira, Inc. (2015) Summary page 4.

## Most influential descendants
- K223607: Plum Duo™ Infusion System (2023), 2 descendants of its own
- K183311: Ivenix Infusion System (IIS) (2019), 1 descendant of its own
- K242114: Plum Solo™ Precision IV Pump (2025), 0 descendants of its own
- K242115: Plum Duo™ Precision IV Pump (2025), 0 descendants of its own
- K213089: Ivenix Infusion System, LVP Epidural Administraion Set NRFit Connector (2021), 0 descendants of its own

## Recalls of this device
- May 7, 2024 · Class I · Z-2447-2024: Due to a manufacturing defect from the battery supplier, affected batteries may experience a loss of capacity earlier in the battery lifecycle than expected and overall battery runtime may decrease ea
- Jul 13, 2023 · Class II · Z-2430-2023: Due to a manufacturing defect of a supplier provided component, there is a potential that the audible signal for an alarm may not sound under certain conditions.
- Mar 22, 2023 · Class I · Z-1565-2023: Due to a manufacturing defect from the battery supplier, affected batteries may experience a loss of capacity earlier in the battery lifecycle than expected and overall battery runtime may decrease ea
- Aug 1, 2018 · Class II · Z-0171-2020: A software malfunction of the infuser when used with a MedNet Custom Drug Library (CDL). When a new CDL is downloaded and installed on the infuser the infuser can become inoperable and show a blank sc
- Oct 30, 2017 · Class II · Z-0101-2018: (1) Under certain conditions, if a malfunction alarm occurs while the pump is in the "Paused" state waiting for the distal pressure to decrease, the pump cannot be turned off and delivery cannot be re
- Jun 15, 2017 · Class II · Z-3031-2017: Potential for the Connectivity Engine Module of the affected unit to disengage from the main chassis, causing the unit to shut down without an alarm notification. This would delay initiation of therap

## Indications for use
Plum 360™ Infusion System with Hospira MedNet™ is indicated for use in parenteral, enteral and epidural therapies and the administration of whole blood and blood products.

Source page: https://510kreport.com/device/K161469
Methodology: https://510kreport.com/methodology