inforMED
MalfunctionQAX

THERANOVA 400

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

Report MW5175586 · MDR key 22955575

Device

Generic name

Hemodialyzer With Expanded Solute Removal Profile

Lot number

4-6901-H-01

Product problems

  • Contamination of Device Ingredient or Reagent

Patient

NA · Unknown

  • Hemorrhage/Blood Loss/Bleeding
  • Thrombosis/Thrombus
  • Hemorrhage/Blood Loss/Bleeding
  • Thrombosis/Thrombus

Narrative

Description of Event or Problem

2ND REPORT - SAME ISSUE WAS EXPERIENCED BY 2 PATIENTS ON SAME DAY WITH SAME PRODUCT 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.