inforMED
MalfunctionFPB

MEDEX

Received Apr 18, 2023 · Event occurred Mar 31, 2023

Report 16761249 · MDR key 16761249

Device

Generic name

Filter, Infusion Line

Model number

MX448HFB

Catalog number

MX448HFB

Lot number

4355305

Product problems

  • Obstruction of Flow
  • Audible Prompt/Feedback Problem

Patient

3650 DA · Female

  • Insufficient Information
  • Insufficient Information

Narrative

Description of Event or Problem

IV PUMP ALARMING OCCLUSION, CLAMPS OPEN, LINE PATENT, AND NO KINKS. UPON DISCONNECTING LINE, NO FLOW. DECIDED TO CHANGE FILTER - LINE BEGAN TO FLOW FREELY. FILTER HAD BEEN PREVENTING FLOW FOR SOME REASON. HAPPENED X2 THUS FAR THIS SHIFT.