smiths medical Medfusion Model 3500 Syringe pump

Medfusion syringe pumps, with software versions before v6.0.0, may have the following issues:1. Delivery During Motor Not Running High Priority Alarm, 2. Infusion Restarted with Incorrect Parameters, 3. Screen Lock, 4. Interruption of Bolus or Loading Dose Delivery, 5. Pump Displays Incorrect Bolus/Loading Dose, 6. Loading/Bolus Dose Below the Minimum Recommended Rate, 7. Motor Rate Error, 8. Incorrect Recall Last Settings, 9. Corrupt Configuration, 10. Auto Lock, 11. Toolbox Configuration Loading Dose Time Values. 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 (v6.0.0) installed on your pumps.

Smiths Medical issued an URGENT MEDICAL DEVICE CORRRECTION notice to its consignees on 12/16/2023 by letter delivered via traceable means. 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 [email protected] 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 [email protected]. Inquires: To report adverse events or product complaints: Global Complaint Management, [email protected], 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