# K982159: Abbott Plum a+ Infusion Pump

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: Jan 12, 1999 after 207 days
- Product code: FRN (Pump, Infusion)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: 11 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
12 later devices descend from it; 3 cite it directly.
5 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## 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 29, 2019 · Class II · Z-0126-2020: Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.
- Feb 25, 2014 · Class II · Z-1479-2014: Hospira identified an incorrect lower lid (set component) had been supplied and was being used during the manufacturing process of list number 11241-03, a HemoSet containing a burette and blood filter
- Sep 9, 2013 · Class II · Z-2059-2016: Intravenous fluid may leak at the CLAVE secondary port of Hospira PlumSet IV administration sets.
- Sep 9, 2013 · Class II · Z-2062-2016: Intravenous fluid may leak at the CLAVE secondary port of Hospira PlumSet IV administration sets.
- Feb 1, 2013 · Class II · Z-0285-2014: 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-0205-2014: 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

## Indications for use
The Plum A+ Infusion Pump is indicated for use in parenteral, enteral and epidural therapies and the administration of whole blood and blood products.

Source page: https://510kreport.com/device/K982159
Methodology: https://510kreport.com/methodology