# K042800: Lifecare Pca Infusion System with Hospira Mednet Software

- Pathway: 510(k) (Traditional)
- Applicant: Hospira, Inc.
- Decided: Oct 18, 2004 after 10 days
- Product code: MEA (Pump, Infusion, Pca)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: 5 (0 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). 6 ancestors in all.
3 later devices descend from it; 3 cite it directly.
3 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022203: Abbott Lifecare Pca 3 Infuser, Model 12384, Abbott Laboratories (2002) Summary page 1.
- K042081: Plum a+ Infusion System with Hospira Mednet Software , and Plum a+3 Infusion System with Hospira Mednet Software, Hospira, Inc. (2004) Summary page 1.

## Most influential descendants
- K043256: Hospira Lifecare Infusion System, Model 12384-04-07; Lifecare Pca Infusion System Sterile Empy Vials, Model 6021-04-03 (2004), 1 descendant of its own
- K143612: LifeCare PCA Infusion System (2016), 0 descendants of its own
- K083019: Gemstar SP Infusion System with Gemstar SP Infusion Suite Software (2008), 0 descendants of its own

## Recalls of this device
- Mar 8, 2013 · Class II · Z-2141-2016: Hospira has received reports of PCA pumps not detecting distal occlusions, one of which resulted in a serious injury. The issue is caused by normal wear and tear on the Half Nut (the component/nut tha
- Mar 8, 2013 · Class II · Z-2873-2016: Screw rotation error occurring when the pump detects a mismatch between the number of steps given to the motor driving delivery and the number of steps the motor actually took. When this malfunction o
- Mar 8, 2013 · Class II · Z-2874-2016: Screw rotation error occurring when the pump detects a mismatch between the number of steps given to the motor driving delivery and the number of steps the motor actually took. When this malfunction o
- Feb 27, 2013 · Class II · Z-1518-2015: The infusion pump has a clear plastic door that, due to its design, allows for excessive flexing. This in turn permits unauthorized access to the vial of medication.
- Aug 11, 2009 · Not classified · Z-0018-2010: Fire/Shock hazard-- A component used in the device may cause sparks/flashes and poses a fire and shock hazard.

## Indications for use
The LifeCare PCA ® Infusion System with Hospira MedNetTM Software is indicated for accurate, volumetric, infusion of analgesic drugs by continuous or patient-demanded (PCA) intravenous administration. It is also indicated for short-term (less than 96 hours) continuous administration of analgesic drugs.

Source page: https://510kreport.com/device/K042800
Methodology: https://510kreport.com/methodology