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
