MalfunctionFPB
MEDEX FILTER SET
Received Mar 4, 2022 · Event occurred Jan 1, 2022
Report 3012307300-2022-04346 · MDR key 13670244
Device
Generic name
Filter, Infusion Line
Manufacturer
Smiths Medical Asd, Inc.Model number
MX448HFBCatalog number
MX448HFB
Lot number
4180739
Product problems
- No Flow
- No Flow
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
ONE FILTER SET WAS RECEIVED FOR EVALUATION IN RELATION TO THE REPORTED EVENT. EVALUATION OF THE DEVICE IS CURRENTLY IN PROGRESS. ONCE THE EVALUATION IS COMPLETE, A FOLLOW-UP REPORT WITH EVALUATION RESULTS WILL BE SUBMITTED.
Description of Event or Problem
IT WAS REPORTED THAT THE IV FLUID IS NOT RUNNING THROUGH THE ADMINISTRATION SET. THERE WAS NO PATIENT INJURY REPORTED.