CADD

Additional Manufacturer Narrative

A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE.

Description of Event or Problem

IT WAS STATED THAT THE WIRELESS CONNECTION WAS INTERMITTENTLY NOT WORKING. IT SHOWED AN ERROR WIRELESS MODULE INTERMITTENT CONNECTION WITH PUMP SERIAL NUMBER CN-332872. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM/ADVERSE EVENT REPORTED.

Additional Manufacturer Narrative

RECEIVED ONE DEVICE. IT WAS REPORTED THAT THE WIRELESS CONNECTION PROBLEM COULD NOT BE DUPLICATED. EVALUATION COULD NOT DUPLICATE THE REPORTED FAILURE AFTER ALL ATTEMPTS TESTING THE COMMUNICATION MODULE ON A KNOWN GOOD SOLIS PUMP. REVIEW OF EVENT HISTORY LOG FROM THE HOST PUMP ON SEPARATE COMPLAINT SHOWED REPEATED EVENTS OF THE FAILURE FOLLOWED BY UNEXPECTED POWER DOWNS. BASED ON THE EVALUATION RESULTS, NO FAULT WAS FOUND WITH THE WIRELESS CONNECTIVITY FUNCTIONS OF THE COMMUNICATION MODULE.