—#128401

Product

The Hospira MedNet Medication Management Suite (MMS). Product Usage: The Hospira MedNet Medication Management Suite (MMS) is intended to facilitate networked communication between MMS compatible computer systems and Hospira infusion pumps. The MMS provides trained healthcare professionals with the capability to send, receive, report, and store information from interfaced external systems, and to configure and edit infusion programming parameters. The MMS is intended to provide a way to automate the programming of infusion parameters, thereby decreasing the amount of manual steps necessary to enter infusion data. All data entry and validation of infusion parameters is performed by a trained healthcare professional according to physicians orders.

FDA product code: FRN — Pump, Infusion
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K042609
Affected lot / code info: 1) Software Version 5.5, List Number: 16037-04-13; 2) Software Version 5.8.1, List Number: 16037-04-31; 3) Software Version 5.8.2, List Number: 16037-04-33

Why it was recalled

Hospira MedNet 5.5, 5.8.1, and 5.8.2 contains software defect where the dosing units of "nanog/kg/min" and "milliUnits/min" are not sent to a Plum A+ device (Version 13.40, 13.41, and 13.4.2) via Auto Programming when those dosing units are not properly established in the customized drug library. A dosing unit mismatch of "nanog/kg/min" or "milliUnits/min" on an unmatched medication will produce a

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

Hospira sent an URGENT MEDICAL DEVICE CORRECTION letter dated June 6, 2014 was sent to all affected customers. The letter included instructions for customers to: notify all potential users in their organization of the recall, and to complete and return the attached reply form. The letter further notified customers that they will be contacted by a member of Hospira's Clinical Services Team to make arrangements to review the drug library and implement the appropriate mitigation. Hospira will further work with the direct account to ensure Auto Programming installations receive Pharmacy consulting to support the implementation of the mitigation and that a correction for this issue will be addressed in a future version of the software. Reports of adverse events or product complaints can be made by contacting Hospira Global Complaint Management at 800-441-4100 (Monday - Friday, 8:00 AM - 5:00 PM CST) or via e-mail at ProductComplaintsPP@hospira.com. Additional information or technical assistance can be obtained by contacting the Hospira Advanced Knowledge Center at 800-241-4002, option 4 (24 hours a day, 7 days a week).

Recalling firm

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

Distribution

Distribution pattern: US Nationwide in the states of FL, LA, PA, WA, WY and the country of Hong Kong

Timeline

Recall initiated: 2014-06-06
Posted by FDA: 2014-07-10
Terminated: 2016-12-06
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #128401. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.