CADD SOLIS COMM MODULE
Received Oct 28, 2024 · Event occurred Oct 1, 2024
Report 3012307300-2024-12191 · MDR key 20549686
Device
Generic name
Accessories, Pump, Infusion
Manufacturer
Smiths Medical Asd, Inc.Catalog number
21-2131-25
Lot number
18489537
Product problems
- Failure to Infuse
- Wireless Communication Problem
- Failure to Infuse
- Wireless Communication Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
D9: PRODUCT RECEIVED DATE 08-NOV-2024. H3: ONE DEVICE WAS RETURNED FOR ANALYSIS. DEVICE HISTORY 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. CORRECTIVE ACTION IS IN PLACE.
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 AN INTERMITTENT CONNECTIVITY ALARM AND WOULD NOT RUN. THERE WAS NO PATIENT INVOLVEMENT.