510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-2027-2014Class II

The Hospira MedNet Medication Management Suite (MMS)

Abbott Medical / initiated 2014-06-06 / Terminated / root cause: software

Hospira Inc. began a recall of The Hospira MedNet Medication Management Suite (MMS). Product Usage: The Hospira MedNet Medication Management Suite (MMS) is intended to facilitate networked... on . FDA classified it as Class II and gives the reason as "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...". As of , the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number
Z-2027-2014
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Abbott Medical
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.
Product code
FRN Pump, Infusion
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
Root cause tag
software
FDA root 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 [email protected]. 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
Product codes and lots
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

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-2027-2014
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-2027-2014Class IITerminatedVoluntary: Firm initiated