inforMED
MalfunctionQAX

THERANOVA 400

Received Sep 3, 2025 · Event occurred Aug 27, 2025

Report MW5175568 · MDR key 22954769

Device

Generic name

Hemodialyzer With Expanded Solute Removal Profile

Lot number

4-6901-H-01

Product problems

  • Break
  • Fluid/Blood Leak

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

BLOOD CLOTTED DURING DIALYSIS TREATMENT. WHILE ATTEMPTING TO RINSE BACK THE PATIENTS BLOOD THE FIBERS INSIDE THE DIALYZER BROKE OPEN AND WE HAD A "BLOOD IN DIALYSATE" ALARM. BLOOD WAS NOT ABLE TO BE RETURNED TO PATIENT CAUSING A LOSS OF 300ML. RN WAS NOTIFIED. NEW MACHINE WAS STARTED AND TREATMENT WAS RESTARTED ON NEW MACHINE.