# K070398: Hospira Plum a+ Infusion Pump, Model 12391

- Pathway: 510(k) (Special)
- Applicant: Hospira, Inc.
- Decided: Apr 24, 2007 after 71 days
- Product code: FRN (Pump, Infusion)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: 21 (4 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K011442 (2001). 6 ancestors in all.
No later device cites it as a predicate yet.
4 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052052: Hospira Plum a+ Infusion Pump System V11.5, Hospira Plum a+ 3 Infusion Pump System, V11.5, Hospira, Inc. (2005) Summary page 1.
- K024084: Abbott Plum a+ Infusion Pump, Model 12391, Abbott Laboratories (2002) Summary page 1.

## 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-1072-2015: 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-0287-2014: 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-2681-2017: A possible interruption of therapy when an E321 error code occurs while using the infuser, which is caused by battery issues.
- Feb 1, 2013 · Class II · Z-2683-2017: A possible interruption of therapy when an E321 error code occurs while using the infuser, which is caused by battery issues.
- Feb 1, 2013 · Class II · Z-2675-2017: A possible interruption of therapy when an E321 error code occurs while using the infuser, which is caused by battery issues.
- Feb 1, 2013 · Class II · Z-2678-2017: A possible interruption of therapy when an E321 error code occurs while using the infuser, which is caused by battery issues.
- Feb 1, 2013 · Class II · Z-2680-2017: A possible interruption of therapy when an E321 error code occurs while using the infuser, which is caused by battery issues.
- Feb 1, 2013 · Class II · Z-2677-2017: A possible interruption of therapy when an E321 error code occurs while using the infuser, which is caused by battery issues.
- Feb 1, 2013 · Class II · Z-2679-2017: A possible interruption of therapy when an E321 error code occurs while using the infuser, which is caused by battery issues.
- Feb 1, 2013 · Class II · Z-2676-2017: A possible interruption of therapy when an E321 error code occurs while using the infuser, which is caused by battery issues.
- Feb 1, 2013 · Class II · Z-2682-2017: A possible interruption of therapy when an E321 error code occurs while using the infuser, which is caused by battery issues.
- 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-0207-2014: 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-0024-2010: Fire/Shock hazard-- A component used in the device may cause sparks/flashes and poses a fire and shock hazard.

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

Source page: https://510kreport.com/device/K070398
Methodology: https://510kreport.com/methodology