—#114120

Product

Plum A+ Hyperbaric Single Channel Infusion Pumps with Hospira MedNet Software and a Connectivity Engine peripheral module that provides wired Ethernet and wireless local networking, allowing the MedNet software to download drug libraries to the infuser and enable the auto-programming feature; Hospira, Inc., Lake Forest, IL 60045; pump list number 11005, module list number 11006 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: pump list number 11005 and module list number 11006; all serial numbers

Why it was recalled

The volume control knob on some Plum A+ single channel infusers (located on the back of the infuser) may not function as described in the System Operating Manual - the direction for Loud and Quiet may be reversed. The manual indicates a clockwise rotation of the knob decreases the volume; however, on some of the devices the alarm volume increases when the knob is turned clockwise.

Root cause (FDA determination)

Device Design

Action the firm took

The firm, Hospira Inc. sent "URGENT DEVICE FIELD CORRECTION" letters dated October 26, 2012 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 the firm via fax at 1-877-650-8667. The letter states that the System Operating Manual will be updated to clarify the instructions for setting the volume, and that the updated manuals will be sent as soon as they are available. 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 additional information and technical assistance.

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 countries of Australia, Bahrain, Belgium, Brazil, Canada, Chile, Colombia, Denmark, France, Greece, Hong Kong, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Korea, Kuwait, Lebanon, Libya, Malaysia, Mexico, Netherlands, New Zealand, Oman, Pakistan, Philippines, Poland, Portugal, Saudi Arabia, Singapore, Lavenia, South Africa, Spain, Switzerland, Taiwan, Turkey, United Kingdom, United Arab Emirates and Vietnam.

Timeline

Recall initiated: 2012-10-26
Posted by FDA: 2012-12-07
Terminated: 2016-11-14
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #114120. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.