CADD SOLIS COMM MODULE
Received Jun 23, 2025 · Event occurred Jun 1, 2025
Report 3012307300-2025-07510 · MDR key 22309786
Device
Generic name
Accessories, Pump, Infusion
Manufacturer
Icu Medical, Inc.Catalog number
21-2131-25
Lot number
12798149
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 THERE WAS COMMUNICATION MODULE INTERMITTENT CONNECTION. PATIENT INVOLVEMENT WAS UNKNOWN.
Additional Manufacturer Narrative
D4: EXPIRATION DATE AND H4: MANUFACTURE DATE IS UNKNOWN; NO INFORMATION IS AVAILABLE BASED ON REPORTED LOT NUMBER. B3: DATE OF EVENT IS 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 REPORTABLE INFORMATION BECOMES AVAILABLE.
Additional Manufacturer Narrative
A1: UPDATED. H3 AND H6 CODES: UPDATED. NO PRODUCT WAS RETURNED. THE REPORTED ISSUE CANNOT BE CONFIRMED AS NO PRODUCT WAS RETURNED FOR INVESTIGATION. IF THE PRODUCT IS RETURNED, THIS COMPLAINT WILL BE REOPENED FOR FURTHER INVESTIGATION. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED WHICH INDICATED ALL INSPECTIONS WERE COMPLETED AND NO ISSUES WERE NOTED DURING MANUFACTURE.