—#205373

Product

smiths medical Medfusion Model 4000 syringe pump

FDA product code: FRN — Pump, Infusion
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K111386
Affected lot / code info: All Medfusion Model 4000 with software versions: v1.0.0, v1.1.0, v1.1.1, v1.1.2, v1.5.0, v1.5.1, 1.6.0, v1.6.1, v1.6.4, v2.3, v2.4, v2.5, and all versions prior to v1.6.5.

Why it was recalled

Medfusion Model 4000 syringe infusion pumps, with the following software versions, may have the following issues: 1. Delivery During Motor Not Running High Priority Alarm (v1.0.0, v1.1.0, v1.1.1, v1.1.2), 2. Re-administered Loading Dose (v1.0.0, v1.1.0, v1.1.1, v1.1.2), 3. Incorrect Critical Data Failure Alarm, 4. Interruption of Bolus or Loading Dose Delivery (v1.0.0, v1.1.0, v1.1.1, v1.1.2), 5. Incorrect Total Bolus/Loading Dose Displayed (v1.1.0, v1.1.1, v1.1.2), 6. Volume Limit Before Bolus/Loading Dose Complete (v1.1.2), 7. Drug Library Lower Limit Displayed Incorrectly (v1.6.0, v1.6.1), 8. Depleted Battery Alarm (All versions previous to v1.6.5), 9. Loss of Wireless Connectivity (v1.5.0, v1.5.1, v1.6.0, v1.6.1, v1.6.4), 10. PharmGuard Server Password (v2.3, v2.4, v2.5). Smiths Medical corrected all issues included in this notification in previous software updates and the corrections were carried forward into all subsequent software releases. Please ensure you have the most recent Medfusion software installed on your pumps.

Root cause (FDA determination)

Software Design Change

Action the firm took

Smiths Medical issued an URGENT MEDICAL DEVICE CORRRECTION notice to its consignees on 12/19/2023 by letter delivered via traceable means. This notification details the issues and the affected software versions. Please note that the pump displays the installed software version on the startup screen after the pump is powered on. The notice explained the issues with the pumps, the potential risks involved with their use, and requested the following actions be taken: 1. Locate all affected pumps in your possession and ensure all users or potential users of these devices are immediately made aware of this notification and proposed mitigations. Please ensure you have the most recent Medfusion software installed on your pumps. 2. Complete and return the attached Response Form to smithsmedical8045@sedgwick.com within ten days of receipt to acknowledge your understanding of this notification. 3. DISTRIBUTORS: If you have distributed potentially affected products to your customers, please immediately forward this notice to them. Request that they complete the response form and return it to smithsmedical8045@sedgwick.com. To report adverse events or product complaints: Global Complaint Management, globalcomplaints@icumed.com, 1-(866)-216-8806 Additional information or technical assistance: Technical Support, icumed.custhelp.com/app/market-action Questions about this Field Correction Notice: Field Corrections, icumed.custhelp.com/app/market-action

Recalling firm

Firm: Smiths Medical ASD Inc.
Address: 6000 Nathan Ln N, Minneapolis, Minnesota 55442-1690

Distribution

Distribution pattern: US nationwide, Canada, Great Britain, Bermuda, Australia, Germany, Singapore, Saudi Arabia, Lebanon, and Malaysia

Timeline

Recall initiated: 2023-12-19
Posted by FDA: 2024-02-01
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #205373. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.