MalfunctionMRZ
CADD SOLIS COMM MODULE
Received Jul 14, 2025 · Event occurred Jun 1, 2025
Report 3012307300-2025-08334 · MDR key 22501306
Device
Generic name
Accessories, Pump, Infusion
Manufacturer
Icu Medical, Inc.Model number
UNKNOWNCatalog number
UNKNOWN
Product problems
- Wireless Communication Problem
- Wireless Communication Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
B3: UNKNOWN; NO INFORMATION HAS BEEN PROVIDED TO DATE. H3: 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 REPORTABLE INFORMATION BECOMES AVAILABLE.
Description of Event or Problem
IT WAS REPORTED THAT THE DEVICE HAD A PUMP CONNECTION ISSUE. THE ALARM DISPLAYED: "WIRELESS MODULE INTERMITTENT CONNECTION WITH PUMP." THE ISSUE WAS NOT RESOLVED. THE EVENT OCCURRED AT THE HOSPITAL. THERE WAS UNKNOWN PATIENT INVOLVEMENT.