—#159493

Product

ICU Mednet(TM) Medication Management Suite 6.1 and 6.21, Product Code/List Numbers: (a) 16037-64-01; MedNet 6.1 b) 16037-64-02; MedNet 6.1 c) 16037-64-03; MedNet 6.1 d) 16037-64-04; MedNet 6.21 The ICU Medical MedNet Medication Management Suite (MMS) is intended to facilitate networked communication between MMS compatible computer systems and MedNet compatible 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 physician s orders.

FDA product code: FRN — Pump, Infusion
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K141102
Affected lot / code info: All MedNet 6.1 and 6.21 installations

Why it was recalled

Issue 1: The MedNet Meds 6.1 and 6.21 programs, under certain conditions, can change the piggyback medication entry set settings for existing defined medication entries. This includes (a) whether a medication may be piggybacked and (b) whether an infusion may be interrupted by a piggyback. This only occurs when: 1. Medication entries are built with the same displayed name and diluent amount AND; 2. The piggyback or interruptible settings differ from one CCA to another AND; 3. The drug library is exported then imported into the MedNet Meds program. The changed drug library may then be finalized and downloaded to infusers for use in clinical settings. The changes are made without any notice provided to either the MedNet Meds user (pharmacist) or to the clinician operating the infuser that the piggyback or interruptible settings have been altered. Issue 2: The MedNet Meds 6.1 program, under certain conditions different from those described above in Issue 1, can change the piggyback medication entry set settings for existing defined medication entries. This includes (a) whether a medication may be piggybacked and (b) whether an infusion may be interrupted by a piggyback. This only occurs when: 1. The Master Drug Formulary contains medication entries built with the same displayed name and diluent amounts but one is a Limited rule set and the other is a Full rule set AND; 2. The medication entry built as the Full rule set has a blank medication amount with the medication units in mg AND; 3. Both medication entries have different piggyback options set AND; 4. The drug library is exported then imported into the MedNet Meds program. In this case, the piggyback options will be changed during an import of such drug library.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

ICU Medical sent an Urgent : Medical Device Correction letter dated October 30, 2017, Please Inform potential users in your organization of this notification and complete the attached response form and return it to the fax number or e-mail address on the form,even if you do not have the affected product. If you have distributed the product further, notify your accounts that received the product identified above of this notification and ask them to contact Stericycle at 1-855-215-5460 (M-F,8am-5pm ET) to receive a reply form. ICU Medical is committed to patient safety and is focused on providing exceptional product reliability and the highest level of customer satisfaction. Thank you for your prompt support on this important matter. We appreciate your cooperation.

Recalling firm

Firm: ICU Medical Inc
Address: 600 N Field Dr, Lake Forest, Illinois 60045-4835

Distribution

Distribution pattern: Worldwide Distribution - USA (nationwide) Distribution and to the countries of : Canada, Australia and Philippines

Timeline

Recall initiated: 2017-10-30
Terminated: 2020-09-03
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #159493. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.