Class 2 Device Recall Hospira MedNet Medication Management Suite

• Date Initiated by Firm: June 06, 2014
• Date Posted: July 10, 2014
• Recall Status: Terminated on December 06, 2016
• Recall Number: Z-2027-2014
• Recall Event ID: 68658
• 510(K)Number: K042609
• Product Classification: Pump, infusion - Product Code FRN
• 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.
• Code Information: 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
• Recalling Firm/ Manufacturer: Hospira Inc.; 275 N Field Dr; Lake Forest IL 60045-2579
• For Additional Information Contact: Hospira Global Compliant Management; 800-441-4100
• Manufacturer Reason for Recall: 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
• FDA Determined Cause: Under Investigation by firm
• Action: 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).
• Quantity in Commerce: 13 units
• Distribution: US Nationwide in the states of FL, LA, PA, WA, WY and the country of Hong Kong
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = FRN