# K021350: Abbott Plum a+3 Multichannel Infusion Pump, Model 12348

- Pathway: 510(k) (Special)
- Applicant: Abbott Laboratories
- Decided: May 14, 2002 after 15 days
- Product code: FRN (Pump, Infusion)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
29 later devices descend from it; 3 cite it directly.
11 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Abbott Plum A+™ Single Channel Infusion Pump: named in the summary without a submission number

## Most influential descendants
- K042081: Plum a+ Infusion System with Hospira Mednet Software , and Plum a+3 Infusion System with Hospira Mednet Software (2004), 27 descendants of its own
- K052052: Hospira Plum a+ Infusion Pump System V11.5, Hospira Plum a+ 3 Infusion Pump System, V11.5 (2005), 12 descendants of its own
- K103224: Hospira Plum Infusion Set; Hospira Infusion Set with Yellow Stripe Tubing (2011), 10 descendants of its own
- K141789: Plum 360 Infusion System with Hospira Mednet, Smart Card Plug N Play CE 3.0 Module for Plum a+ Infusion System Upgrade (2015), 9 descendants of its own
- K161469: Plum 360(TM) Infusion System with MedNet/ Smart Card Plug and Play Module (2017), 5 descendants of its own

## Recalls of this device
- Feb 1, 2013 · Class II · Z-0286-2014: Plum A+ infusers have the potential for the distal (occlusion) press sensor pin to break. The distal pressure sensor pin is a part of the overall subsystem that measures the pressure within the distal
- Dec 7, 2012 · Class II · Z-0625-2013: The door roller assembly on the Plum A+/A+3 infuser family of infusers has the potential to break which can lead to possible unrestricted flow and/or over-delivery during the removal of the IV adminis
- Feb 5, 2012 · Class II · Z-0206-2014: Hospira has received reports of distal pressure sensor calibration drift on Plum A+ Infusers. The following error codes may be displayed during setup or infusion signifying possible calibration drift:
- Aug 11, 2009 · Not classified · Z-0023-2010: Fire/Shock hazard-- A component used in the device may cause sparks/flashes and poses a fire and shock hazard.
- Sep 8, 2004 · Not classified · Z-0439-05: The batteries in Plum A+ and Plum A+3 I.V. infusion pumps may fail prematurely when the pump is operating solely on battery power.
- Sep 8, 2004 · Not classified · Z-0438-05: The batteries in Plum A+ and Plum A+3 I.V. infusion pumps may fail prematurely when the pump is operating solely on battery power.

## Indications for use
Indicated for use in parenteral, enteral and epidural therapies and the administration of whole blood and blood products.

Source page: https://510kreport.com/device/K021350
Methodology: https://510kreport.com/methodology