An urgent field safety notice issued in Europe warns of software issues with some CADD-Solis ambulatory infusion pumps made by Smiths Medical.
The ICU Medical unit corrected some issues in previous software updates but some problems persist.
For starters, according to the communication, the infusion pump may not alarm for an upstream occlusion.
This issue could occur when the upstream occlusion (USO) sensor is turned off in the protocol, the pump infuses with an administration set and bag and an upstream occlusion occurs. With an occlusion present, an administrator logs in with an administrator security code to enable the USO sensor.
If the administrator does nothing to clear the USO, the pump remains in delivery mode. However, it fails to display an alarm for the upstream occlusion.
According to Smiths Medical, an upstream occlusion without an alert may result in underdelivery. The company received no reports of injury or death related to this issue.
Other issues include unresponsive stop and power keys, manual mode air detector failure and single bubble air detection failures. To date, Smiths Medical reports no injuries or deaths related to these issues.
Additionally, the company reports a failure to display error codes at power-up, defective audible alarms, and low air in line sensitivity detection thresholds. The company’s pumps also had an issue with passwords for logging into the server. Again, Smiths Medical received no reports of injuries or deaths related to these problems.
The Smiths Medical safety notice lists the full extent of each potential issue with the infusion pumps.
