CADD SOLIS COMM MODULE

Additional Manufacturer Narrative

D9: PRODUCT RECEIVED DATE 11/8/2024. H3: ONE DEVICE WAS RETURNED FOR ANALYSIS WITH COMPLAINT THAT THE DEVICE HAD AN INTERMITTENT CONNECTIVITY ALARM AND WOULD NOT RUN. 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. COMPLAINT THAT THE DEVICE HAS WIRELESS MODULE INTERMITTENT CONNECTION ISSUES COULD NOT BE DUPLICATED. EVALUATION FOUND THE COMM MODULE CONNECTING TO THE PUMP PROPERLY AND WAS BEING DETECTED WITHOUT ERRORS WHEN PAIRED WITH A KNOWN GOOD OPERATING PUMP. TESTING DID FIND THE COMM MODULE FAILING TO ENABLE ITS WIRELESS SETTINGS AND CONNECT TO THE WIRELESS NETWORK. THE MOST PROBABLE CAUSE IS A MALFUNCTIONING WIRELESS RADIO BOARD. COMM MODULE IS BEING SENT TO SUPPLIER FOR FURTHER ANALYSIS.

Additional Manufacturer Narrative

B3: UNKNOWN; NO INFORMATION HAS BEEN PROVIDED TO DATE. 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 DEVICE HAD WIRELESS MODULE INTERMITTENT CONNECTION ISSUES. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM/ADVERSE EVENT REPORTED.