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Recall Observatory FDA recall evidence

Device product

smiths medical Medfusion Model 3500 Syringe pump

Z-0863-2024

December 19, 2023

Class I

Product summary

Firm
Smiths Medical ASD Inc.
Event
Event 93754
Status
Ongoing
Classification
Class I
Quantity
93177 pumps
Official record key
device-enforcement:Z-0863-2024

Official wording

Reason: 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.

Code information: All Medfusion Model 3500 pumps with software v3.X, v4.X, and v5.0.0 and was addressed in software v6.0.0 (2012) and all subsequent versions.

Distribution pattern: worldwide

Derived failure modes

  • Device software or design

    reason.device_software_design · v1.0.0

    software versions before v6.0.0, may