Cl II Hospira Plum 360 Infusion Pump

Company: Hospira, Inc.
Date of Enforcement Report 4/5/2017
Class lI:

PRODUCT

Plum 360 Infusion Pump, Software Version 15.02. The infusion pump is capable of delivering fluids for a variety of therapies such as parenteral, enteral, or epidural infusions
Recall Number Z-1682-2017

REASON
Depleted Battery alarm shows instead of Replace Battery. On battery power, ongoing therapy stops, alarms show and sound, pump shuts down after 3 minutes. On AC power, the pump reboots (takes about 25 seconds). Therapy can resume. AC power interruption of 3-7 seconds prompts an incorrect E323 alarm, ongoing therapy stop, and pump reboot. Longer power loss results in battery power operation.

RECALLING FIRM/MANUFACTURER
Hospira, Inc., Lake Forest, IL on 12/30/2016. Voluntary: Firm Initiated recall is ongling.

VOLUME OF PRODUCT IN COMMERCE
862,847 units

DISTRIBUTION
Nationwide and Internationally

___________________________________

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.

Cybersecurity Review

Our cybersecurity experts can quickly remediate cybersecurity deficiencies with your medical device or digital health software.  Planning, requirements, validation, and submissions – we can assist with all.

Interested in having a conversation?  Email us to arrange a Zoom meeting or call us at +1 781-721-2921.

office@softwarecpr.com

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.