Smiths Medical issued a recall for its Medfusion Model 3500 syringe pump due to issues associated with earlier software versions.
The ICU Medical unit issued the recall as a correction — not a product removal. It affects 85,961 pumps distributed between Aug. 9, 2022, and Aug. 15, 2023. Smiths Medical initiated the infusion syringe pump recall on Dec. 19, 2023. The recall affects all those exposed to the pump, especially vulnerable patients. That includes those in the neonatal intensivecare unit (NICU) and cardiac intensive care unit (CICU) treated with Medfusion 3500.
Smiths Medical reports one injury and no deaths related to this issue, according to an FDA notice.
This latest recall follows last month’s FDA Class I recall for more than 50,000 Medfusion Model 4000 pumps. Similarly, the company recalled those models due to a software issue.
In this case, Smiths Medical identified issues associated with software versions before its v.6 version. Issues associated with the earlier software include a high-priority alarm for delivery during motor not running, restarting infusion with incorrect parameters, screen lock problems, interruptions in bolus or loading dose delivery, incorrect display of bolus/loading dose information, doses falling below the minimum recommended rate, motor rate errors, incorrect recall of last settings, corrupt configurations, auto lock issues and problems with the toolbox configuration loading dose time values.
Smiths Medical’s urgent medical device correction letter instructed customers to locate all affected pumps and ensure all users are aware of the notification and proposed mitigations. Users should also confirm all pumps have the most recent Medfusion software installed.
