MC3 ECMO OXYGENATOR

Additional Manufacturer Narrative

MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

Description of Event or Problem

MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF AN AP40 CENTRIFUGAL PUMP AND A MC3 NAUTILUS EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) OXYGENATOR, IT WAS REPORTED THAT THE PUMP HEAD WAS DAMAGED AND BECAUSE THIS WAS A COMPLETE EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) SYSTEM, THE ENTIRE SYSTEM WAS REMOVED AND REPLACED WITH ANOTHER BRAND. BLOOD LEAKAGE OCCURRED ON THE MC3 NAUTILUS OXYGENATOR DUE TO THE DAMAGED PUMP HEAD. BOTH DEVICES WERE REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.