CADD-SOLIS COMM MODULE

Description of Event or Problem

IT WAS REPORTED, THAT UPON IMPLEMENTATION, THE PUMP HAD AN OUT OF BOX FAILURE. WITH WIRELESS INTERMITTENT CONNECTION WITH PUMP. THERE WAS NO PATIENT INVOLVEMENT.

Additional Manufacturer Narrative

ONE DEVICE WAS RECEIVED, WITH THE HOST CADD SOLIS PUMP TO BE EVALUATED TOGETHER. EVALUATION FOUND THE FAILURE OCCURRING, WHEN THE COMM MODULE IS TESTED ON ITS HOST PUMP, WITH AC POWER ADAPTER PLUGGED IN. AND IDENTIFIED, THE COMM MODULE WAS NOT FULLY LATCHING INSIDE ITS HOST PUMP. THE FAILURE OCCURRED, WITH OR WITHOUT A POLE MOUNT CAPTURE MOUNTED, BUT NOT REPEATING, WHEN A KNOWN GOOD TEST SOLIS PUMP WAS SWAPPED. DETERMINED, THE HOST PUMP WAS CONTRIBUTING TO THE FAILURE.