PlainRecalls
FDA Devices Critical Class I Ongoing

smiths medical Medfusion Model 3500 Syringe pump

Reported: February 7, 2024 Initiated: December 19, 2023 #Z-0863-2024

Product Description

smiths medical Medfusion Model 3500 Syringe pump

Reason for Recall

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.

Details

Recalling Firm
Smiths Medical ASD Inc.
Units Affected
93177 pumps
Distribution
worldwide
Location
Minneapolis, MN

Frequently Asked Questions

What product was recalled?
smiths medical Medfusion Model 3500 Syringe pump. Recalled by Smiths Medical ASD Inc.. Units affected: 93177 pumps.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on February 7, 2024. Severity: Critical. Recall number: Z-0863-2024.