inforMED
MalfunctionFPK

MEDEX

Received Jan 27, 2026 · Event occurred Dec 27, 2025

Report 24188181 · MDR key 24188181

Device

Generic name

Tubing, Fluid Delivery

Manufacturer

Icu Medical, Inc.

Model number

MX43660

Lot number

4457071

Patient

59 YR · Female

  • Transfusion Reaction

Narrative

Description of Event or Problem

MULTIPLE STAFF AT PATIENT'S BEDSIDE IN THE SETTING OF ELEVATED DELTA PS ON ECMO [EXTRACORPOREAL MEMBRANE OXYGENATION]. TEAM WAS INSPECTING THE PIGTAIL TUBING FOR CLOTS/FIBRINS AND TUBE SNAPED OFF AT THE LEUR LOCK OF THE ECMO CIRCUIT. THE ECMO CIRCUIT WAS BRIEFLY CLAPPED OFF TO REPLACE TUBING. THE PATIENT LOST BLOOD AND LATER HAD TO BE TRANSFUSED ONE UNIT TO REPLACE BLOOD LOST DURING INCIDENT. ATTENDING ICU PHYSICIAN AT BEDSIDE AS WELL AS MULTIPLE ECMO SPECIALIST AT TIME OF CLAMPING OFF ECMO. PATIENT WAS HYPOTENSIVE AND BEING SUPPORTED ON VASOPRESSORS. BOTH INFLOW AND RETURN CANNULAS WERE CLAMPED OFF <10 SECONDS IN ORDER TO REPLACE PIGTAIL TUBING. FLOWS ON ECMO REESTABLISHED WITHIN 30 SECONDS AND ABLE TO COME OFF OF VASOPRESSORS.