CADD SOLIS COMM MODULE
Received Jul 25, 2025 · Event occurred Jul 8, 2025
Report 3012307300-2025-08941 · MDR key 22611624
Device
Generic name
Accessories, Pump, Infusion
Manufacturer
Icu Medical, IncCatalog number
21-2131-01
Lot number
20033270
Product problems
- Failure to Infuse
- Failure to Infuse
- Wireless Communication Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
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 INFORMATION BECOMES AVAILABLE. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER.
Description of Event or Problem
IT WAS REPORTED THAT THE DEVICE HAD EXPERIENCED AN INTERMITTENT WIRELESS MODULE CONNECTIVITY ALARM, WHICH WAS AN OUT-OF-BOX FAILURE DURING ITS IMPLEMENTATION AT THE CUSTOMER'S LOCATION. THE EVENT OCCURRED DURING BENCH TEST AT THE HOSPITAL.
Additional Manufacturer Narrative
D1, D2A, D2B D4: UPDATE. H3 AND H6 CODES: UPDATED. D4: EXPIRATION DATE AND H4: MANUFACTURE DATE IS UNKNOWN; NO INFORMATION IS AVAILABLE BASED ON REPORTED LOT NUMBER. 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.