MEDEX IV FILTER EXTENSION SET
Received Jul 7, 2026 · Event occurred Feb 1, 2026
Report 1526863-2026-00137 · MDR key 25732424
Device
Generic name
Filter, Infusion Line
Manufacturer
Icu Medical Healthcare Manufacturing S.a. De C.vCatalog number
FS116
Product problems
- Fluid/Blood Leak
- Increase in Pressure
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE PRODUCT SEEMED TO FAIL AS THERE WERE OVERPRESSURE ALARMS AND SOLUTION LEAKED FROM THE FILTER. THERE WAS UNKNOWN PATIENT INVOLVEMENT.
Additional Manufacturer Narrative
B3 - DATE OF EVENT - UNKNOWN.H3 AND H6 ¿ UPDATED.THIS FILE WAS ORIGINALLY INCORRECTLY FILED UNDER REGISTRATION NUMBER MRN 3012307300-2026-02305. THE DATE OF THAT SUBMISSION WAS 11-MAR-2026.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.