FDA-Device2024-02-07Class I

smiths medical Medfusion Model 3500 Syringe pump

Smiths Medical ASD Inc.

Hazard

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.

Sold states

worldwide

Affected count

93177 pumps

Manufactured in

6000 Nathan Ln N, Minneapolis, MN, United States

Products

smiths medical Medfusion Model 3500 Syringe pump

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0863-2024

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