Cl II Plum A+ Infusion System

Company:Hospira Inc.
Date of Enforcement Report: 7/30/2014
Class lI:

PRODUCT

The Plum A+ Infusion System is designed to meet the fluid delivery requirements of today’s evolving healthcare environments. It is a cassette based multi-function infusion system. The Plum A+ allows two lines in and one line out. The pump can be used for standard, piggyback, or concurrent delivery. Therapy modes include: Standard Infusions, Multistep Programming, Loading Dose, and Dose Calculation. The Plum A+ is designed to deliver parenteral, enteral, or epidural infusions over a broad range of infusion rates from multiple fluid container types. Each system includes a pumping module and an assortment of disposable IV sets, optional accessories, and an operator’s manual. Recall Number V-144-2014

REASON
The is a possible interruption of therapy which may occur when in E321 error code occurs while using a Plum A+ infuser. The E321 error code occurs when the Plum A+ infuser is operating on AC power and the software detects that the batter could not be fully recharged within eight hours. If the E321 error code occurs during infusion, the infuser will stop delivery, which may result in a delay/interruption of therapy.

RECALLING FIRM/MANUFACTURER
Hospira Inc., Lake Forest, IL on 3/12/2013 Voluntary: Firm Initiated recall is ongoing

VOLUME OF PRODUCT IN COMMERCE
467 pumps

DISTRIBUTION
Nationwide

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About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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