—#104077

Product

Plum A+ Hyperbaric Single Channel Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045; list 11005 Product Usage: The Plum A+ Hyperbaric Infusion System is exclusively designed for hyperbaric therapy in monospace and multiplace chambers.

FDA product code: FRN — Pump, Infusion
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K081412
Affected lot / code info: list 11005, serial numbers 0016792207 through 0018807700

Why it was recalled

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 the original default setting. This condition could cause a delay in therapy if the clinician is unable to start the device due to the continuous recycling and/or rebooting.

Root cause (FDA determination)

Software design

Action the firm took

The firm, Hospira sent "URGENT DEVICE RECALL" letters dated September 16, 2011 to all affected customers. The letters identified the products, problem and action(s) to be taken. The customers were instructed to read the information provided carefully, complete the attached Reply Form and return it to Hospira via fax at 1-888-345-5358. The letter states that a software upgrade to address the issue is currently being developed. Customers were instructed to notify their consignees if they have further distributed the affected product. The customers were requested to contact Hospira Advanced Knowledge Center at 1-800-241-4002, option 4, for technical assistance. *** Follow-up letters dated June 26, 2012 were sent to the accounts listing the device modules with software versions v13.2, v13.3, v13.40 and v13.5 that will require the software upgrade. ***

Recalling firm

Firm: Hospira Inc.
Address: 275 N Field Dr, Lake Forest, Illinois 60045-2579

Distribution

Distribution pattern: Worldwide Distribution - USA (nationwide) including Puerto Rico and the US Virgin Islands, and countries of: Argentina, Australia, Bahamas, Barbados, Belgium, Brazil, Canada, Chile, Colombia, Costa Rica, Denmark, Dominican Republic, Ecuador, France, Greece, Hong Kong, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Korea, Kuwait, Lebanon, Libya, Malaysia, Mexico, Netherlands, New Zealand, Oman, Pakistan, Peru, Philippines, Poland, Portugal, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, United kingdom, United Arab Emirates, Uruguay and Vietnam.

Timeline

Recall initiated: 2011-09-16
Posted by FDA: 2011-10-04
Terminated: 2016-11-07
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #104077. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.