inforMED
MalfunctionDQE

ICU MEDICAL

Received Jul 21, 2026 · Event occurred Jun 10, 2026

Report 25889227 · MDR key 25889227

Device

Generic name

Catheter, Oximeter, Fiber-optic

Manufacturer

Icu Medical, Inc.

Model number

41240-05

Catalog number

412400405

Patient

66 YR · Male

  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

PRIMARY RN NOTIFIED ME AT 7:00 AM THAT THE PA [PULMONARY ARTERY] CATHETER WAS NOT READING A BLOOD TEMPERATURE; THEREFORE, CARDIAC OUTPUT/INDEX IS NOT ABLE TO BE OBTAINED VIA THERMODILUTION. WE SWAPPED OUT BOTH THE MODULE THAT CLICKS INTO THE PHILLIPS MONITOR, ALONG WITH CARDIAC OUTPUT CABLE. NEITHER INTERVENTION WAS SUCCESSFUL. THE PRONGS ON THE PA CATHETER APPEAR INTACT AND NOT BENT. PRIMARY RN NOTIFIED THE 1ST CALL MD. UPON REVIEW, THE PA CATHETER WAS PLACED [REDACTED] AT 12:39. THE LINE HAS BEEN DWELLING LESS THAN 24 HOURS. THE LAST SET OF HEMODYNAMIC VALUES VIA THERMODILUTION WAS [REDACTED]-THE SAME DAY AT 20:12. ON [REDACTED]-THE NEXT DAY AT 04:46, THE NIGHT SHIFT DOCUMENTED NOT BEING ABLE TO OBTAIN NUMBERS DUE TO THE TEMPERATURE NOT READING AND HAD NOTIFIED THE MD.