CADD SOLIS COMM MODULE
Received Sep 2, 2025 · Event occurred Aug 1, 2025
Report 3012307300-2025-10159 · MDR key 22932109
Device
Generic name
Accessories, Pump, Infusion
Manufacturer
Icu Medical, Inc.Catalog number
21-2131-25
Lot number
19481649
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
D4, LOT#: UPDATED. D9, DATE RETURNED TO MFG: 3/4/2026. H3 AND H6 CODES, UPDATED. THE SUSPECTED DEVICE WAS RETURNED FOR EVALUATION. THE DEVICE WAS VISUALLY INSPECTED, AND 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. LOT HISTORY IS WITH THE MANUFACTURER THEREFORE MANUFACTURING BATCH REVIEW COULD NOT BE PERFORMED.
Description of Event or Problem
IT WAS REPORTED THAT THE COMMUNICATION MODULE HAD ¿COMMUNICATION MODULE INTERMITTENT CONNECTION" ERROR WITH THE PUMP. THE EVENT OCCURRED AT THE HOSPITAL. SAMPLE PHOTO WAS PROVIDED FOR INVESTIGATION. THERE WAS NO REPORTED PATIENT INVOLVEMENT. ASSOCIATED PUMP COMPLAINT WAS DOCUMENTED ON (B)(4).
Additional Manufacturer Narrative
D4 - LOT: POTENTIAL- #: 19481649. 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.