PlainRecalls
FDA Devices Moderate Class II Terminated

The Plum A+ is a dual-line volumetric infusion system designed to meet the growing demand for hospital-wide, as well as alternate site and home healthcare, standardization. With its primary line, secondary line, and piggyback fluid delivery capability, the Plum A+ is suited for a wide range of medical/surgical and critical care applications. Full compatibility with LifeCare Plum Series administration sets and accessories. Each system includes a pumping module (hereafter called the infuser) a

Reported: June 15, 2016 Initiated: March 25, 2016 #Z-1833-2016

Product Description

The Plum A+ is a dual-line volumetric infusion system designed to meet the growing demand for hospital-wide, as well as alternate site and home healthcare, standardization. With its primary line, secondary line, and piggyback fluid delivery capability, the Plum A+ is suited for a wide range of medical/surgical and critical care applications. Full compatibility with LifeCare Plum Series administration sets and accessories. Each system includes a pumping module (hereafter called the infuser) and an assortment of disposable IV sets (hereafter called a set), and optional accessories. The Plum A+ host device contains a Connectivity Engine peripheral module that provides wired Ethernet and wireless 802.11 a/b/g local area networking capabilities. This allows the Hospira Mednet networked application software to download drug libraries to the infuser and enable the autoprogramming feature.

Reason for Recall

Firm's investigation determined that the Proximal Occlusion Alarms observed in the field were attributed to the mechanism calibration process being performed with an out of specification metal cassette, resulting in an offset in proximal pressure.

Details

Recalling Firm
Hospira Inc.
Units Affected
2567 Plum A+ infusion pumps.
Distribution
U.S. distribution : Natrionwide. Foreign :Brazil, Canada, Chile, Colombia, Ecuador, Guatemala, Mexico, Oman, Peru, Taiwan, Turkey, United Kingdom and Uruguay.
Location
Lake Forest, IL

Frequently Asked Questions

What product was recalled?
The Plum A+ is a dual-line volumetric infusion system designed to meet the growing demand for hospital-wide, as well as alternate site and home healthcare, standardization. With its primary line, secondary line, and piggyback fluid delivery capability, the Plum A+ is suited for a wide range of medical/surgical and critical care applications. Full compatibility with LifeCare Plum Series administration sets and accessories. Each system includes a pumping module (hereafter called the infuser) and an assortment of disposable IV sets (hereafter called a set), and optional accessories. The Plum A+ host device contains a Connectivity Engine peripheral module that provides wired Ethernet and wireless 802.11 a/b/g local area networking capabilities. This allows the Hospira Mednet networked application software to download drug libraries to the infuser and enable the autoprogramming feature.. Recalled by Hospira Inc.. Units affected: 2567 Plum A+ infusion pumps..
Why was this product recalled?
Firm's investigation determined that the Proximal Occlusion Alarms observed in the field were attributed to the mechanism calibration process being performed with an out of specification metal cassette, resulting in an offset in proximal pressure.
Which agency issued this recall?
This recall was issued by the FDA Devices on June 15, 2016. Severity: Moderate. Recall number: Z-1833-2016.