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.
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