CADD SOLIS COMM MODULE

Description of Event or Problem

IT WAS REPORTED THAT DEVICE HAS WIRELESS MODULE INTERMITTENT CONNECTION ISSUES. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM/ADVERSE EVENT REPORTED.

Additional Manufacturer Narrative

ONE DEVICE WAS RETURNED FOR ANALYSIS IN GOOD CONDITION. 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. EVALUATION FOUND THE COMM MODULE CONNECTING TO THE PUMP PROPERLY AND WAS BEING DETECTED WITHOUT ERRORS WHEN PAIRED WITH A KNOWN GOOD OPERATING PUMP. EVALUATION 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. DEVICE IS BEING SENT TO SUPPLIER FOR FURTHER ANALYSIS. B3. DATE OF EVENT: UNKNOWN. NO INFORMATION HAS BEEN PROVIDED TO DATE.