CADD-SOLIS WIRELESS COMMUNICATION MODULE
Received Jun 16, 2025 · Event occurred May 1, 2025
Report 3012307300-2025-07154 · MDR key 22212778
Device
Generic name
Accessories, Pump, Infusion
Manufacturer
Icu Medical, Inc.Product problems
- Failure to Infuse
- Wireless Communication Problem
- 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
H3, H6: 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.
Description of Event or Problem
IT WAS REPORTED THAT THERE WAS A HIGH PRIORITY ALARM "411000" SYSTEM FAULT DURING CLINICAL USE. THIS HIGH PRIORITY ALARM EVENT PAUSES THE DELIVERY OF THE PUMP UNTIL THE ERROR IS ADDRESSED. THERE WAS UNKNOWN PATIENT INVOLVEMENT, AND UNKNOWN SIGNS OR SYMPTOMS EXPERIENCED.
Additional Manufacturer Narrative
H6. CODES: UPDATED. DEVICE EVALUATION: COMPLAINT FOR THE FAILURE MODE "HIGH PRIORITY ALARM "411000"; SYSTEM FAULT DURING CLINICAL USE" COULD NOT BE CONFIRMED AS NO SAMPLES OR PICTURES WERE PROVIDED BY THE CUSTOMER. WITHOUT THE RETURN OF THE SAMPLE(S) A COMPREHENSIVE FAILURE INVESTIGATION CANNOT BE PERFORMED, AND A PROBABLE CAUSE CANNOT BE DETERMINED. IF THE PRODUCT IS RETURNED THE MANUFACTURER WILL RE-OPEN THE COMPLAINT FOR FURTHER DEVICE ANALYSIS. THIS MALFUNCTION DOES NOT AFFECT THE FUNCTION OF THE DEVICE IN A WAY THAT COULD LIKELY RESULT IN DEATH OR SERIOUS INJURY.