CADD SOLIS COMM MODULE

Additional Manufacturer Narrative

ONE DEVICE WAS RETURNED FOR ANALYSIS. FUNCTIONAL AND VISUAL TESTS WERE PERFORMED, AND THE REPORTED ISSUE WAS NOT DUPLICATED. THE CAUSE OF THE REPORTED ISSUE WAS DUE TO A MALFUNCTIONING WIRELESS RADIO BOARD. A DHR REVIEW IS NOT APPLICABLE IN THIS CASE BECAUSE ITEM IS A PURCHASED FINISHED GOOD, MANUFACTURING RECORDS ARE RETAINED BY THE SUPPLIER AT THEIR MANUFACTURING SITE AND ARE NOT READILY AVAILABLE FOR REVIEW.

Description of Event or Problem

IT WAS REPORTED THAT THE PUMP'S COMM-MODULE WAS DEFECTIVE, AND THE WIRELESS MODULE WAS EXPERIENCING AN INTERMITTENT CONNECTION WITH THE PUMP. THERE WAS NO PATIENT INVOLVEMENT, AND NO ADVERSE EVENT WAS REPORTED.