VITALFLOW SET

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. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

Description of Event or Problem

IT WAS REPORTED THAT NOISE WAS OBSERVED IN THE VITALFLOW TUBE SET PUMP DURING ITS USE IN A VENTRICULAR FIBRILLATION PROCEDURE. THERE WAS A CLOT IN PUMP INLET CAUSING NOISE. THE CLINICIAN ATTEMPTED TO SET THE PUMP TO 0 RPM AND RESEAT THE DEVICE TO ENSURE THE MAGNET WAS PROPERLY COUPLED, BUT THE PUMP CONTINUED TO PRODUCE NOISE. THE PATIENT WAS SAFELY WEANED FROM SUPPORT. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

Additional Manufacturer Narrative

D.4.SERIAL NUMBER UPDATED. 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.

Additional Manufacturer Narrative

MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE FLOW VARIED, BUT DID NOT STOP. NO LEAKS WERE NOTED WITH THE DEVICE. THE PUMP WAS ON SUPPORT (VEN-OVENOUS) ON THE 17-FEBRUARY-2025, VENO-VENOUS FAILED EXPLANT (CLOT IN PUMP) ON THE (B)(6) 2025. THE PUMP HAD NOT BEEN DAMAGED IN ANY WAY. THE PUMP HEAD WAS NOT WARM TO THE TOUCH. CLOTTING WAS PRESENT IN THE CIRCUIT. DEVICE EVALUATION SUMMARY: VISUAL INSPECTION SHOWS EVIDENCE OF CLOTS AROUND THE TOP AND BOTTOM PIVOT. ADDITIONAL VISUAL INSPECTION UNDER MAGNIFICATION SHOWS EVIDENCE OF DAMAGE TO THE UPPER PIVOT. THE DEVICE WAS TESTED PER SPECIFICATION. THE DEVICE WAS RUN ON A BIO CONSOLE FROM 0-4000 RPM¿S, USING FLUID, A NOISE LEVEL GREATER THAN 70 DB WAS RECORDED, SPECIFICATION IS LESS THAN 68 DB. REASON FOR RETURN WAS CONFIRMED. 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.