VACUUM RELIEF VALVE

Additional Manufacturer Narrative

ADDITIONAL INFORMATION B5: MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THERE WAS MINIMAL BLOOD LOSS. AN UNPLANNED BLOOD TRANSFUSION WAS NOT REQUIRED AS A RESULT OF THE LEAK. 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 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 CARDIOPULMONARY BYPASS, THE VACUUM RELIEF VALVE (VRV) EXPERIENCED A LEAK, RESULTING IN DRIPPING BLOOD. THE USE OF THE DEVICE WAS UNSPECIFIED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

Additional Manufacturer Narrative

DEVICE EVALUATION SUMMARY: UPON RECEIPT IN OUR QUALITY ANALYSIS LAB, VISUAL INSPECTION SHOWS NO OUTWARD SIGNS OF ANY DAMAGE. THE DEVICE HAD A TEST MARK, WHICH CONFIRMED THE VRV WAS TESTED PRIOR TO DISTRIBUTION. FUNCTIONAL TESTING OF THE RETURNED DEVICE WAS PERFORMED AT 0.5 L/MIN. THE INSTRUCTIONS FOR USE PROVIDES AN APPROXIMATION FOR FIRST TIME USE OF NEGATIVE AND POSITIVE PRESSURES TO OPEN THE UMBRELLA RELIEF VALVES AT 0.5 L/MIN BLOOD FLOW ARE APPROXIMATELY -205 MMHG AND 318 MMHG. OUR RESULTS INDICATED THE NEGATIVE PRESSURE UMBRELLA OPENED AT -205 MMHG AND THE POSITIVE PRESSURE UMBRELLA VALVE OPENED AT 353 MMHG VERIFYING THE FUNCTIONALITY FOR THE VALVES FOR THE RETURNED DEVICE. THE ACCEPTABLE FUNCTION OF THE UMBRELLA VALVES ALSO CONFIRMS THE DUCK BILL VALVE FUNCTIONED AS INTENDED. THERE WAS NO LEAKING OBSERVED. REASON FOR THE RETURN WAS NOT 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.