inforMED
MalfunctionDTR

MPS3 ND CONSOLE

Received Feb 20, 2026 · Event occurred Jan 21, 2026

Report 1649914-2026-00008 · MDR key 24402130

Device

Generic name

Cardiopulmonary Bypass Heat Exchanger, Product Code: Dtr

Model number

5301000ND

Product problems

  • Insufficient Device Problem Information

Patient

Unknown

  • No Clinical Signs, Symptoms or Conditions

Narrative

Additional Manufacturer Narrative

A FOLLOW-UP REPORT WILL BE SUBMITTED AFTER INVESTIGATION IS COMPLETED.

Description of Event or Problem

REPORT STATES UNIT PRIMED WITHOUT ISSUE WITH A 1:4 DELIVERY RATIO SET. UPON ATTEMPTING TO RUN UP CARDIOPLEGIA THE VENT VALVE KEPT OPENING AND CLOSING SO MUCH SO THAT RETROGRADE FLOW WAS NOTICED IN THE DELIVERY LINE. THE PERFUSIONIST HAD TO MANUALLY CLAMP THE VENT LINE DURING THE RUN UP AND DURING THE CASE.