# K052052: Hospira Plum a+ Infusion Pump System V11.5, Hospira Plum a+ 3 Infusion Pump System, V11.5

- Pathway: 510(k) (Special)
- Applicant: Hospira, Inc.
- Decided: Aug 24, 2005 after 26 days
- Product code: FRN (Pump, Infusion)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: 11 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K011442 (2001). 5 ancestors in all.
12 later devices descend from it; 2 cite it directly.
9 of 18 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 2.
- K024084: Abbott Plum a+ Infusion Pump, Model 12391, Abbott Laboratories (2002) Summary page 2.
- K021350: Abbott Plum a+3 Multichannel Infusion Pump, Model 12348, Abbott Laboratories (2002) Summary page 2.
- K011442: Abbott Plum a+Infusion Pump, Model 11971, Abbott Laboratories (2001) Summary page 2.

## Most influential descendants
- 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
- 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

## Recalls of this device
- Jul 2, 2014 · Class I · Z-1075-2015: One lot of alarm assemblies used in Plum A+ and Plum A+3 infusion pumps may fail to sound at all volume levels.
- Sep 9, 2013 · Class II · Z-2061-2016: Intravenous fluid may leak at the CLAVE secondary port of Hospira PlumSet IV administration sets.
- Feb 1, 2013 · Class II · Z-0288-2014: 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
- Oct 26, 2012 · Class II · Z-0481-2013: The volume control knob on some Plum A+ single channel infusers (located on the back of the infuser) may not function as described in the System Operating Manual - the direction for Loud and Quiet may
- Feb 5, 2012 · Class II · Z-0208-2014: 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:
- Sep 16, 2011 · Not classified · Z-0010-2012: Hospira has received reports of continuous recycling and/or rebooting of Plum A+ infusion pumps when the backlight intensity and/or display contrast settings for the LED display has been adjusted from
- Sep 16, 2011 · Not classified · Z-3285-2011: Hospira has received reports of incorrect seating of the regulator closer on the Plum A+ Infusion Pumps. If the regulator closer does not close the flow regulator actuator when the pump door is opened
- Feb 14, 2011 · Not classified · Z-1645-2011: Hospira has received customer reports of the Plum A+ infusion pumps with no audible alarm conditions, which have been associated with failure of the piezoelectric assembly due to component quality iss
- Nov 24, 2009 · Not classified · Z-1349-2010: Reports of difficulty in adjusting the flow rate, which could result in flow rate variances.
- Aug 11, 2009 · Not classified · Z-0026-2010: Fire/Shock hazard-- A component used in the device may cause sparks/flashes and poses a fire and shock hazard.

## 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/K052052
Methodology: https://510kreport.com/methodology