PERFUSION TUBING SYSTEM

Description of Event or Problem

LIVANOVA USA INC. RECEIVED REPORT OF A PERFUSION TUBING SYSTEM DISCONNECTION DURING AN ECMO PROCEDURE. IN DETAILS, THE PIGTAIL/PRESSURE WAS IN-LINE IN A PUMP ARTERIAL TO PUMP VENOUS SHUNT FROM THE TOP PORT OF THE OXYGENATOR TO A PRE CENTRIFUGAL PUMP HEAD VENOUS ACCESS PIGTAIL. REPORTEDLY, THE PIGTAIL/PRESSURE LINE GOT DISCONNECTED AND MASSIVE AIR WAS ENTRAINED INTO THE VENOUS PRE PUMP HEAD CIRCUIT; MINIMAL BLOOD LOSS OCCURRED FROM THE TOP PORT OF THE OXYGENATOR. THE PATIENT WAS REMOVED FROM ECMO AND WENT INTO CARDIAC ARREST, AND CPR WAS REQUIRED. THE ECMO CIRCUIT WAS IMMEDIATELY REPLACED AND CPR WAS STOPPED WITHIN THE FIRST MINUTE AFTER FLOW WAS RESTARTED. PATIENT WAS OFF ECMO FOR APPROXIMATELY 6 MINUTES. LIVANOVA RECEIVED VOLUNTARY REPORT FROM FDA REF. MW5185938.

Additional Manufacturer Narrative

A.1.-A.5. PATIENT INFORMATION WAS NOT PROVIDED. H11: THROUGH FOLLOW-UP COMMUNICATIONS, LIVANOVA LEARNED THAT PATIENT IS STILL ON VV ECMO SUPPORT. TRANSFUSION OF 1 UNIT PRBCS WAS REQUIRED, FOR A DECREASE IN HEMATOCRIT FROM 35.8 PRE-INCIDENT TO 34.2 POST -INCIDENT, REFLECTIVE OF THE HEMODILUTION DUE TO CIRCUIT REPLACEMENT FROM A BLOOD PRIMED CIRCUIT TO AN ISOLYTE PRIMED CIRCUIT. IN ADDITION, IT WAS REPORTED THAT THE EVENT OCCURRED 32 DAYS AFTER PATIENT WAS PLACED ON ECMO. PERFUSION TUBING SYSTEM ARE VALIDATE UP TO SIX HOURS. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.