Recall Z-2027-2014 ยท FRN Pump, Infusion
Hospira Inc.
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
| Date | Jul 10, 2014 (initiated Jun 6, 2014) |
| Status | Terminated |
| Reason | 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 | 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 |
| Quantity | 13 units |
| Distribution | US Nationwide in the states of FL, LA, PA, WA, WY and the country of Hong Kong |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K042609 | HOSPIRA MEDNET MEDICATION MANAGEMENT SUITE Hospira, Inc., Oct 6, 2004 |