# K011442: Abbott Plum a+Infusion Pump, Model 11971

- Pathway: 510(k) (Special)
- Applicant: Abbott Laboratories
- Decided: Jun 5, 2001 after 26 days
- Product code: FRN (Pump, Infusion)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: 9 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
34 later devices descend from it; 3 cite it directly.
14 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K031185: Abbott Plum a+ Infusion Pump with a HPL/RS Plug-and-Play Module (2003), 32 descendants of its own
- 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
- K041550: Hospira Phoenix Infusion System with Hospira Mednet Software (2004), 13 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

## Recalls of this device
- Jul 2, 2014 · Class I · Z-1071-2015: One lot of alarm assemblies used in Plum A+ and Plum A+3 infusion pumps may fail to sound at all volume levels.
- Feb 1, 2013 · Class II · Z-0284-2014: 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
- 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-0204-2014: 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-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
- 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-0025-2010: Fire/Shock hazard-- A component used in the device may cause sparks/flashes and poses a fire and shock hazard.

Source page: https://510kreport.com/device/K011442
Methodology: https://510kreport.com/methodology