MEDEX 3-WAY STOPCOCK EXTENSION SET

Description of Event or Problem

IT WAS REPORTED THAT DURING ECMO [EXTRACORPOREAL MEMBRANE OXYGENATION] PROCEDURE, THE PIGTAIL TUBING FOR CLOTS OR 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. 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. THE EVENT OCCURRED IN THE HOSPITAL. THE EVENT OCCURRED WHILE IN USE WITH PATIENT. THERE WAS PATIENT HARM REPORTED.

Additional Manufacturer Narrative

B3: YEAR AND MONTH OF EVENT HAS BEEN PROVIDED; DAY IS UNKNOWN. NO PRODUCT WAS RETURNED. THE REPORTED ISSUE CANNOT BE CONFIRMED AS NO PRODUCT WAS RETURNED FOR INVESTIGATION. IF THE PRODUCT IS RETURNED, THIS COMPLAINT WILL BE REOPENED FOR FURTHER INVESTIGATION. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED WHICH INDICATED ALL INSPECTIONS WERE COMPLETED AND NO ISSUES WERE NOTED DURING MANUFACTURE.