# K042081: Plum a+ Infusion System with Hospira Mednet Software , and Plum a+3 Infusion System with Hospira Mednet Software

- Pathway: 510(k) (Traditional)
- Applicant: Hospira, Inc.
- Decided: Aug 24, 2004 after 21 days
- Product code: FRN (Pump, Infusion)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: 19 (4 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K011442 (2001). 4 ancestors in all.
27 later devices descend from it; 6 cite it directly.
12 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031185: Abbott Plum a+ Infusion Pump with a HPL/RS Plug-and-Play Module, Abbott Laboratories (2003) Summary page 1.
- K021350: Abbott Plum a+3 Multichannel Infusion Pump, Model 12348, Abbott Laboratories (2002) Summary page 1.

## Most influential descendants
- 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
- K042609: Hospira Mednet Medication Management Suite (2004), 4 descendants of its own

## Recalls of this device
- May 7, 2024 · Class I · Z-2448-2024: 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
- May 7, 2024 · Class I · Z-2449-2024: 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
- Mar 22, 2023 · Class I · Z-1566-2023: 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 2, 2014 · Class I · Z-1073-2015: One lot of alarm assemblies used in Plum A+ and Plum A+3 infusion pumps may fail to sound at all volume levels.
- Jun 11, 2014 · Class II · Z-1050-2015: Plum A+ infusion system pole clamp assemblies were discovered to be cracked. If the knob on the pole clamp assembly is cracked, the infuser cannot be attached to the IV pole since the knob is used to 
- Feb 1, 2013 · Class II · Z-0289-2014: 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
- Feb 1, 2013 · Class II · Z-0290-2014: 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-0624-2013: 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
- 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-0483-2013: 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-0209-2014: 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-0009-2012: 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-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-3284-2011: 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
- 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
- Feb 14, 2011 · Not classified · Z-1644-2011: 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
- Aug 11, 2009 · Not classified · Z-0027-2010: Fire/Shock hazard-- A component used in the device may cause sparks/flashes and poses a fire and shock hazard.
- Aug 11, 2009 · Not classified · Z-0028-2010: Fire/Shock hazard-- A component used in the device may cause sparks/flashes and poses a fire and shock hazard.

## Indications for use
Plum A+® and Plum A+®3 Infusion Systems with Hospira MedNetTM Software 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/K042081
Methodology: https://510kreport.com/methodology