VITALFLOW SET

Additional Manufacturer Narrative

DEVICE EVALUATION SUMMARY: VISUAL INSPECTION SHOWED EVIDENCE OF CLOTS INSIDE THE DEVICE. ADDITIONAL VISUAL INSPECTION UNDER MAGNIFICATION SHOWED EVIDENCE OF DAMAGE TO THE UPPER PIVOT. THE DEVICE WAS TESTED PER THE SPECIFICATION. THE DEVICE WAS PRIMED AND RUN FROM 0-4000 RPMS ON A BIO-CONSOLE. THE NOISE LEVEL RECORDED DURING THE ANALYSIS WAS LESS THAN 60 DECIBELS, AS COMPARED TO THE SPECIFICATION OF 68 DECIBELS. THE REASON FOR RETURN WAS CONFIRMED FOR CLOTTING. 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 CLOTTING AND FLOW ISSUES OCCURRED IN THE VITALFLOW TUBE SET PUMP AFTER 8 DAYS ON CARDIOPULMONARY BYPASS. THE BLOCKAGE, CLOT, AND FLOW ISSUE WERE LOCATED IN THE PUMP HEAD. A NOISE WAS HEARD FROM THE PUMP. THE PATIENT WAS NOT ON ANTI-COAGULATION THERAPY DUE TO POSTPARTUM STATUS, THE CUSTOMER TRIED TO MAINTAIN 4L/MIN OR MORE. THE ISSUE WORSENED OVER TIME. ANTI-COAGULATION WAS ASSESSED USING ACT AND THE PRIMING SOLUTION USED WAS PLASMALYTE. THE DEVICE WAS REPLACED TO COMPLETE THE CASE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

Additional Manufacturer Narrative

CORRECTION D2: PRODUCT CODE AND COMMON DEVICE NAME 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

FDC CODE 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.