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. 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 A MC3 NAUTILUS VITALFLOW (VF) BIO-PUMP AND MC3 NAUTILUS VITALFLOW (VF) EXTRA CORPOREAL MEMBRANE OXYGENATION (ECMO) OXYGENATOR, IT WAS REPORTED THAT THE VITAL FLOW CONE WAS RATTLING OR LOOSE. THEY DID NOT OBSERVE A CLOT WHEN THEY RINSED IT OUT. THE LOOSE/SEPARATED COMPONENT DID NOT FALL INTO THE PATIENT. THE CONE MADE A VERY LOUD NOISE. IT APPEARED LIKE IT WAS BANGING AGAINST SOMETHING. THE CUSTOMER COULD VISUALIZE A WHITE PIECE AT THE PIVOT. IT APPEARED THAT THE LOOSE COMPONENT MAY HAVE BEEN CAUSING THE NOISE. THE CUSTOMER SWITCHED CONSOLES WITH THE SAME CIRCUIT, HOWEVER, THE LOUD NOISE CONTINUED. THE PATIENT HAD BEEN ON ECMO (EXTRACORPOREAL MEMBRANE OXYGENATION) SUPPORT FOR 11 DAYS. THERE WERE NO ISSUES DURING THE 11 DAYS UNTIL IT ABRUPTLY STARTED MAKING A SOUND. THE CUSTOMER COULD OBSERVE THE PIECE VISIBLY IN THE CONE. AT THAT TIME, THEY CAME OFF SUPPORT AND RESET THE SAME MOTOR, HOWEVER, THE SOUND RE-OCCURRED. THERE WERE NO ALARMS. THERE WERE NO PRESSURE DEVIATIONS. THE CLINICAL SPECIALIST STATED THAT IT APPEARED THAT THE BEARING GOT DISCONNECTED. THE DEVICES WERE REPLACED TO A COMPETITIVE CIRCUIT FOR TRANSPORT WITH CARDIOHELP TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT. THE SERIAL NUMBER OF THE OXYGENATOR WAS (B)(6).

Additional Manufacturer Narrative

DEVICE EVALUATION: VISUAL INSPECTION SHOWED EVIDENCE OF DAMAGE TO THE IMPELLER UPPER PIVOT. THE DEVICE WAS PRIMED AND RUN FROM 0-4000 RPMS ON A BIO- CONSOLE. THE NOISE LEVEL RECORDED DURING THE ANALYSIS WAS GREATER THAN 80 DECIBELS, AS COMPARED TO THE SPECIFICATION OF 68 DECIBELS. CONCLUSION: REASON FOR THE 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.