CADD SOLIS COMM MODULE

Additional Manufacturer Narrative

INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

Description of Event or Problem

IT WAS REPORTED THAT THE PUMP ONLY POWERED ON WHEN PLUGGED IN AND DISPLAYED THE FOLLOWING ERROR ON THE SCREEN, WIRELESS MODULE INTERMITTENT CONNECTION WITH PUMP. THE COMMUNICATION MODULE AND BATTERY PACK WERE NOT RECOGNIZED BY THE PUMP. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND UNKNOWN HARM/ADVERSE EVENT WAS REPORTED.

Additional Manufacturer Narrative

DEVICE EVALUATION: ONE DEVICE WAS RECEIVED FOR DEVICE ANALYSIS. FUNCTIONAL TESTING AND VISUAL INSPECTION PERFORMED DURING ANALYSIS. THE CUSTOMER REPORTED COMPLAINT WAS CONFIRMED. IT WAS DETERMINED THAT THE COMMUNICATION MODULE WAS CONSISTENTLY DEVELOPING THE FAILURE WHENEVER ATTACHED TO A PUMP. THE ROOT CAUSE OF THE REPORTED COMPLAINT WAS THE COMMUNICATION MODULE.