AUTOLOG WASH KIT

Description of Event or Problem

MEDTRONIC RECEIVED INFORMATION THAT AFTER THE USE OF AN AUTOLOG IQ INSTRUMENT AND WASH KIT, IT WAS REPORTED THAT THERE WAS A LEAK FROM THE BOTTOM OF THE INSTRUMENT, AND THAT SOME BLOOD LEAKED IN THE WASH KIT BOWL. THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE BIOMED WAS NOT ABLE TO CONFIRM HOW THE BLOOD GOT IN THE WASH KIT BOWL. THE CASE WAS COMPLETED AND DEVICE WAS SET ASIDE BECAUSE BLOOD WAS SEEN LEAKING FROM BOTTOM OF THE INSTRUMENT. THE BIOMED COULD NOT DETERMINE WHETHER THERE WAS A WASH KIT FAILURE.

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.