VITALFLOW SET

Additional Manufacturer Narrative

MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE ANTI-COAGULANT THERAPY USED WITH THE PATIENT WAS HEPARIN. PLASMALYTE-A WAS USED FOR PRIMING. 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

IT WAS REPORTED THAT DURING USE THERE WAS A FLOW ISSUE IN THE VITALFLOW SET WHILE THE PATIENT WAS ON EXTRA CORPOREAL MEMBRANE OXYGENATION (ECMO) SUPPORT FOR SEVERAL DAYS. THE ISSUE WORSENED OVER TIME, AND AN ACUTE DROP IN FLOW WAS OBSERVED, WHICH CORRESPONDED WITH A "GRINDING" SOUND IN THE VENTRICULAR FIBRILLATION PUMP. THE PUMP WAS NOT HOT TO THE TOUCH. THE PATIENT HAD BEEN ON ANTICOAGULANT THERAPY, AND ANTI-COAGULATION WAS ASSESSED USING ACT. THE DEVICE WAS REPLACED TO COMPLETE THE CASE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE PATIENT WAS PLACED ON SUPPORT 7 DAYS PRIOR TO EVENT.

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.