01

Feb

2024

FDA Recall: Old Software Version Leading to Numerous Errors

0

Company: Smiths Medical ASD Inc.
Date of Enforcement Report: 2/1/2014
Class I

PRODUCT

Smith’s Medical Medfusion Model 3500 Syringe pump

Recall Number:

Z-0863-2024

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.

RECALLING FIRM/MANUFACTURER:

Smiths Medical ASD Inc.

VOLUME OF PRODUCT IN COMMERCE:

93177 pumps

DISTRIBUTION:

Worldwide

About the author

Allison Pate

Allison joined SoftwareCPR in 2022, bringing along over ten years of passion for building teamwork and growth in organizations. This is established in part by the greatest University the South has to offer- Mississippi State.

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