MalfunctionMRZ
CADD SOLIS COMM MODULE
Received Jul 14, 2025 · Event occurred Jun 1, 2025
Report 3012307300-2025-08333 · MDR key 22501300
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
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.
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.