CADD LEGACY PCA PUMP
Received Oct 20, 2025 · Event occurred Sep 19, 2025
Report 3012307300-2025-11553 · MDR key 23336796
Device
Generic name
Pump, Infusion, Pca
Manufacturer
Icu Medical, Inc.Model number
6300Catalog number
21-6300-03
Product problems
- Failure to Sense
- Failure to Sense
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE SUSPECTED DEVICE WAS RETURNED FOR EVALUATION. THE EVENT HISTORY LOG (EHL) WAS REVIEWED. THE DEVICE WAS VISUALLY INSPECTED. A FUNCTIONAL TEST WAS PERFORMED AND THE REPORTED ISSUE WAS CONFIRMED. THE CAUSE OF THE REPORTED ISSUE WAS DUE TO THE DOWNSTREAM OCCLUSION SENSOR. AS A RESULT, THE DOWNSTREAM OCCLUSION SENSOR WAS REPLACED. THE SERVICE HISTORY REVIEW HAD NO INDICATION THAT THE COMPLAINT WAS RELATED TO A SERVICE OF THE DEVICE WITHIN THE REVIEW PERIOD. THE DEVICE PASSED ALL FUNCTIONAL TESTING AFTER REPAIR.
Description of Event or Problem
IT WAS REPORTED THAT PUMP EXHIBITED AN OVERPRESSURE ALARM. THERE WAS PATIENT INVOLVEMENT, NO INJURY WAS REPORTED.