CADD-SOLIS WIRELESS COMMUNICATION MODULE
Received Jun 13, 2025 · Event occurred May 1, 2025
Report 3012307300-2025-07052 · MDR key 22205182
Device
Generic name
Accessories, Pump, Infusion
Manufacturer
Icu Medical, Inc.Catalog number
UNKNOWN
Lot number
NI
Product problems
- Pumping Stopped
- Wireless Communication Problem
- Pumping Stopped
- Wireless Communication Problem
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 10019463-001. 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 ERRORS OCCURRED WITH THEIR CADD SOLIS DEVICES, INTERRUPTING PATIENT TREATMENT. PER REPORTER THE ERROR USUALLY READ 'SYSTEM FAULT 46,440 OCCURRED 2,143 3,371 1 22' AND FROZE THE PUMP. THEY WERE ABLE TO CLEAR THE ERROR WHEN THEY CAME ACROSS IT BY DISCONNECTING AND RECONNECTING THE WIRELESS COMMUNICATION MODULE. THERE WAS NO PATIENT HARM. THERE WAS A PATIENT INVOLVEMENT, BUT NO PATIENT HARM REPORTED.
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.