Company: Smiths Medical ASD, Inc.
Date of Enforcement Report: 2/14/2024
Class I
PRODUCT
Smiths Medical, Medfusion Syringe Infusion Pump, Model 4000, Software Version V1.0 & V1.1, Reorder Numbers 4000-0100-50, 4000-0100-95, 4000-0101-50, 4000-0101-51, and 4000-0101-78. Designed for use in care areas for the administration of fluids requiring precisely controlled infusion rates.
Recall Number:
Z-2107-2012
REASON:
Smiths Medical has identified a software anomaly in the Medfusion 4000 Syringe Infusion Pump that causes a device history log corruption and triggers a Watchdog Fail-Safe alarm. When the device exhibits this failure mode, visual and audible alarms will sound and the device ceases operation. Pumps manufactured prior to November 10, 2017, may experience wireless network connectivity issues on certain pumps due to a potential Radio Module issue on some Medfusion 4000 pumps. Inaccurate delivery can occur following an interrupted Bolus or Loading dose, if a specific sequence of events occurs.
Smiths Medical ASD, Inc.
VOLUME OF PRODUCT IN COMMERCE:
607 pumps (257 USA, 350 Canada)
DISTRIBUTION:
Worldwide Distribution — USA, including the state of CA, and country of Canada.
