CADD-SOLIS COMM MODULE
Received Nov 11, 2024 · Event occurred Jul 1, 2024
Report 3012307300-2024-13113 · MDR key 20659002
Device
Generic name
Accessories, Pump, Infusion
Manufacturer
Smiths Medical Asd, Inc.Model number
21-2131-25Catalog number
21-2131-25
Lot number
10343942
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
H3: THE DEVICE WAS RECEIVED FOR EVALUATION. SERVICE HISTORY REVIEW IDENTIFIED THERE WAS NO INDICATION THAT THE COMPLAINT WAS RELATED TO A SERVICE OF THE DEVICE WITHIN THE REVIEW PERIOD. VISUAL AND FUNCTIONAL TESTS WERE PERFORMED WHICH FOUND A DEPLETED BATTERY STATUS AND THE COMM MODULE FAILED TO ENABLE THE WIRELESS SETTINGS OF THE PUMP AND CONNECT TO THE WIRELESS NETWORK. THE CAUSE WAS SUSPECTED TO BE THE WIRELESS RADIO BOARD. THE COMM MODULE IS BEING SENT TO SUPPLIER FOR FURTHER ANALYSIS.
Description of Event or Problem
IT WAS REPORTED THAT THE WIRELESS COMMUNICATION MODULE WAS NOT WORKING (OUT OF BOX). THE RESULTS OF THE INVESTIGATION FOUND THAT THERE WAS A DEPLETED BATTERY STATUS. THERE WAS NO PATIENT INVOLVEMENT, AND NO ADVERSE EVENT REPORTED.