# K141789: Plum 360 Infusion System with Hospira Mednet, Smart Card Plug N Play CE 3.0 Module for Plum a+ Infusion System Upgrade

- Pathway: 510(k) (Traditional)
- Applicant: Hospira, Inc.
- Decided: Jan 16, 2015 after 198 days
- Product code: FRN (Pump, Infusion)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: 11 (2 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K011442 (2001). 24 ancestors in all.
9 later devices descend from it; 2 cite it directly.
11 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042081: Plum a+ Infusion System with Hospira Mednet Software , and Plum a+3 Infusion System with Hospira Mednet Software, Hospira, Inc. (2004) Summary page 4.
- K982159: Abbott Plum a+ Infusion Pump, Abbott Laboratories (1999) Summary page 4.
- K052722: Lifeshield Latex-Free Microbore Extension Set, Model 14949 and Others, Hospira, Inc. (2005) Summary page 4.
- K061432: Hospira Enteral Feeding Set, Model 20640, Hospira, Inc. (2006) Summary page 4.
- K101677: Hospira Infusion Blood Sets, Hospira, Inc. (2010) Summary page 4.
- K103224: Hospira Plum Infusion Set; Hospira Infusion Set with Yellow Stripe Tubing, Hospira, Inc. (2011) Summary page 4.
- K103344: Infusion Sets, Hospira, Inc. (2010) Summary page 5.
- K113683: Lifeshield Vision Infusion Set with Pre-Pierced Reseal, Hospira, Inc. (2012) Summary page 5.

## Most influential descendants
- K161469: Plum 360(TM) Infusion System with MedNet/ Smart Card Plug and Play Module (2017), 5 descendants of its own
- K223607: Plum Duo™ Infusion System (2023), 2 descendants of its own
- K153074: Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding Sets, Kangaroo Connect Portal (2016), 2 descendants of its own
- K183311: Ivenix Infusion System (IIS) (2019), 1 descendant of its own
- K253558: Luminoah FLOW™ Enteral Nutrition System (2026), 0 descendants of its own

## Recalls of this device
- May 12, 2026 · Class II · Z-3162-2026: Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl chloride (PVC) material within the drip chamber 
- 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
- Jul 29, 2019 · Class II · Z-0127-2020: Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.
- Jul 29, 2019 · Class II · Z-0128-2020: Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.
- Jul 29, 2019 · Class II · Z-0145-2020: Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.
- 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
- Dec 30, 2016 · Class II · Z-1682-2017: Depleted Battery alarm shows instead of Replace Battery. On battery power, ongoing therapy stops, alarms show and sound, pump shuts down after 3 minutes. On AC power, the pump reboots (takes about 25 
- Mar 25, 2016 · Class II · Z-1832-2016: Firm's investigation determined that the Proximal Occlusion Alarms observed in the field were attributed to the mechanism calibration process being performed with an out of specification metal cassett
- Mar 25, 2016 · Class II · Z-1833-2016: Firm's investigation determined that the Proximal Occlusion Alarms observed in the field were attributed to the mechanism calibration process being performed with an out of specification metal cassett

## Indications for use
Plum 360™ Infusion System with Hospira MedNet™ and Plum A+™ (360 Enabled™) Infusion System are indicated for use in parenteral, enteral and epidural therapies and the administration of whole blood and blood products.

Source page: https://510kreport.com/device/K141789
Methodology: https://510kreport.com/methodology