The Medfusion 4000 syringe pump is designed to deliver blood, blood products or prescribed drugs into a patient’s body in a controlled manner. They are used primarily in neonatal and pediatric populations in operating rooms, as well as intensive care units for adults.
Smiths Medical became aware of a software issue in the recently updated Firmware Version 1.7.0 for the Medfusion 4000. The issue potentially causes low battery alarms to cease working, which means a user will not receive audible or visual notification that the battery is shutting down.
If the alarm doesn’t sound and the battery shuts down, it could lead to an interruption of therapy that could cause serious injury, adverse events or death. However, no injuries or deaths have been reported, despite 74 complaints related to the software issue.
Product Recalls and Issues
