CADD-SOLIS COMM MODULE

Additional Manufacturer Narrative

ONE DEVICE WAS RECEIVED WITH THE HOST CADD SOLIS PUMP TO BE EVALUATED TOGETHER. THE EVALUATION TEST FOUND THE FAILURE OCCURRING WHEN TESTED ON ITS HOST PUMP WITH THE POLE MOUNT CAPTURE MOUNTED BUT NOT REPEATING WHEN TESTED ON A KNOWN GOOD TEST SOLIS PUMP. DETERMINED THAT THE FAULT WAS WITH THE HOST PUMP NOT THE COMM MODULE. CORRECTIVE ACTIONS ARE IN PROCESS.

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. THE EVENT OCCURRED DURING IMPLEMENTATION OF PUMP AT FACILITY. THERE WAS NO PATIENT INVOLVEMENT.