CADD-SOLIS WIRELESS COMMUNICATION MODULE

Additional Manufacturer Narrative

H2) CORRECTION: D1 BRAND NAME CORRECTED. D4 LOT NUMBER CORRECTED, WAS ORIGINALLY LISTED UNDER SERIAL NUMBER. D4 MODEL NUMBER CORRECTED. D4 EXPIRATION DATE CORRECTED. D4 PRIMARY UDI NUMBER CORRECTED. G2 REPORT SOURCE CORRECTED. G4 PMA/510(K) NUMBER CORRECTED. H4 DEVICE MANUFACTURE DATE CORRECTED. H2) DEVICE EVALUATION: D9: DATE RETURNED TO MANUFACTURER: 7/3/2024. H3, H6: THE DEVICE WAS RETURNED FOR ROOT CAUSE ANALYSIS AND THE INVESTIGATION FINDINGS CONCLUDED AFTER VISUAL INSPECTION AND FUNCTIONAL TESTING, THE CUSTOMER PROBLEM WAS NOT DUPLICATED. THE DEVICE WAS RETURNED IN GOOD CONDITION. WITH THE COMMUNICATION (COMM) MODULE ATTACHED TO A GOOD PUMP AND POWERED-ON TO CHECK BATTERY STATUS, THE MANUFACTURER REPRESENTATIVE CONFIGURED THE PUMP'S WIRELESS SETTINGS USING THE SOLIS NETWORK SETUP UTILITY PER ESTABLISHED SETUP INSTRUCTIONS TO ENABLE WIRELESS COMMUNICATIONS. WITH THE PUMP AND THE COMPUTER CONNECTED TO THE TEST WIRELESS NETWORK (SMTEST5), THE MANUFACTURER REPRESENTATIVE PINGED THE PUMP TO INITIATE DATA TRANSFER. THE REPORTED ERRORS COULD NOT BE DUPLICATED; HOWEVER, THE MANUFACTURER REPRESENTATIVE FOUND THE COMM MODULE TO BE AT FAULT. THE MANUFACTURER REPRESENTATIVE POWERED THE PUMP ON AFTER INSTALLING THE COMM MODULE TO A FULLY CHARGED BATTERY STATE AND NO ERROR MESSAGES APPEARED. THE MANUFACTURER REPRESENTATIVE CONFIGURED THE PUMP SUCCESSFULLY USING THE LATEST VERSION OF SOLIS NETWORK SETUP UTILITY SOFTWARE TO ENABLE THE WIRELESS SETTINGS. HOWEVER, THE COMM MODULE FAILED TO SUCCESSFULLY UPDATE ITS WIRELESS CONNECTIVITY STATUS AND CONNECT TO THE TEST WIRELESS NETWORK AFTER MULTIPLE ATTEMPTS. THE MANUFACTURER REPRESENTATIVE REATTACHED AND RETORQUED THE COMM MODULE'S TOP COVER BUT THAT DID NOT CHANGE THE OUTCOME. THE WIRELESS FUNCTION OF THE PUMP WAS SWITCHED ON BUT THERE WAS NO ASSOCIATION OF THE COMM MODULE WITH A WIRELESS ACCESS POINT OCCURRING. IT APPEARED AS IF THE COMM MODULE WAS STUCK IN HEAT REDUCTION MODE. THE MANUFACTURER REPRESENTATIVE SUSPECTED THE MOST LIKELY CAUSE OF THE CUSTOMER REPORTED ISSUE WAS A MALFUNCTIONING WIRELESS RADIO BOARD. THE MANUFACTURER REPRESENTATIVE SENT A REPLACEMENT REQUEST TO THE CUSTOMER AND WOULD SEND THE DEVICE TO THE SUPPLIER FOR FURTHER INVESTIGATION.

Description of Event or Problem

IT WAS REPORTED THAT MODULE WAS SHOWING FREQUENT "WIRELESS CONNECTION ERROR". WHEN THE ERROR OCCURRED, IT DID NOT ALLOW USER TO PROCEED WITH THE USE OF PUMP. THE ONLY WAY TO CLEAR THE ERROR WAS TO PHYSICALLY REMOVE THE TOP HAT AND RE-ATTACH IT. EVEN WHEN THE COMMUNICATION MODULE WAS SWAPPED WITH ANOTHER PUMP, THE ERROR TRAVELLED WITH IT. REPORTER HAS VERIFIED THAT THERE WERE NO INSULATION RUBBER TIPS LEFT ON THE PINS. THE EVENT OCCURRED DURING START UP. THERE WAS NO PATIENT INVOLVEMENT.

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.