MalfunctionMRZ
CADD SOLIS COMM MODULE
Received Apr 22, 2025 · Event occurred Feb 13, 2025
Report 3012307300-2025-04636 · MDR key 21885740
Device
Generic name
Accessories, Pump, Infusion
Manufacturer
Smiths Medical Asd, Inc.Model number
UNKNOWNCatalog number
21-2131-25
Lot number
13628719
Product problems
- Intermittent Communication Failure
- Intermittent Communication Failure
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE COMMUNICATION MODULE EXHIBITED MULTIPLE WIRELESS INTERMITTENT COMMUNICATION LOSS ERROR WHILE THE PUMP WAS RUNNING. THERE WAS PATIENT INVOLVEMENT, NO PATIENT INJURY WAS REPORTED.
Additional Manufacturer Narrative
ONE DEVICE WAS RECEIVED FOR EVALUATION. A FUNCTIONAL TEST WAS PERFORMED AND THE REPORTED ISSUE WAS NOT DUPLICATED. THE COMMUNICATION MODULE WAS TESTED WITH A WORKING PUMP. THE CAUSE OF THE REPORTED ISSUE WAS UNKNOWN. AS A RESULT, NO FURTHER ACTIONS WERE TAKEN.