CADD SOLIS COMM MODULE
Received Apr 18, 2025 · Event occurred Mar 1, 2025
Report 3012307300-2025-04537 · MDR key 21865774
Device
Generic name
Accessories, Pump, Infusion
Manufacturer
Icu Medical, Inc.Catalog number
21-2131-25
Lot number
13628719
Product problems
- Failure to Infuse
- Failure to Infuse
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. D4 - LOT #: POSSIBLE LOT 13628719. E1 - INITIAL REPORTER PHONE: (B)(6). 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 SHOWED AN ERROR CODE 41100. THERE WAS NO PATIENT INVOLVEMENT.
Additional Manufacturer Narrative
A1, PATIENT IDENTIFIER: CORRECTED. D3, MFG ESTABLISHMENT NAME: CORRECTED. D4, LOT #: UPDATED. H3 AND H6 CODES, UPDATED. D9, DATE RETURNED TO MFG: 6/27/2025. H4: MANUFACTURE DATE IS NOT AVAILABLE BASED ON THE REPORTED LOT NUMBER. THE SUSPECT DEVICE WAS RETURNED FOR EVALUATION. DURING VISUAL INSPECTION, ONE COMMUNICATION MODULE WAS INSPECTED AND FOUND TO BE IN GOOD CONDITION, WITH NO VISIBLE DAMAGE OR ABNORMALITIES NOTED. THE COMMUNICATION MODULE WAS TESTED WITH A KNOWN-GOOD CADD DEVICE AND THE STANDARD LOCAL NETWORK SETUP UTILITY. THE MODULE DID NOT DISPLAY AN IP ADDRESS WHEN ATTEMPTING TO CONNECT. A DEVICE HISTORY RECORD (DHR) REVIEW COULD NOT BE PERFORMED FOR THE GIVEN LOT NUMBER.