CADD SOLIS COMM MODULE

Additional Manufacturer Narrative

E1 - INITIAL REPORTER PHONE: (B)(6). 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 WIRELESS MODULE EXHIBITED AN ERROR AND INTERMITTENT CONNECTION WITH THE PUMP. THERE WAS NO PATIENT INVOLVEMENT, NO PATIENT INJURY WAS REPORTED.

Additional Manufacturer Narrative

D9: 29-APR-2025. H3: ONE DEVICE WAS RETURNED FOR ANALYSIS IN NORMAL CONDITION WITH NO PHYSICAL DAMAGE NOTED. FUNCTIONAL TESTING WAS PERFORMED, AND THE DEVICE SUCCESSFULLY CONNECTED THE COMM MODULE WITH THE NETWORK UTILITY AND ALLOWED THE DEVICE TO STAY ON FOR 2 HOURS WITH NO ERROR MESSAGES DISPLAYED. THE COMPLAINT WAS NOT REPLICATED AND THEREFORE A PROBABLE CAUSE COULD NOT BE DETERMINED.