MEDTRONIC RECEIVED INFORMATION REPORTING THAT DURING USE OF THIS HMS PLUS IN A PROCEDURE, THE COAGULATION TEST RESULTS DID NOT MEET THE USER'S EXPECTATIONS AS BLOOD COTS APPEARED ON THE PERICARDIUM. THE USER DOUBTED THE ACCURACY OF THE INSTRUMENT. USE OF THE INSTRUMENT WAS CONTINUED WITH NO RESULTING ADVERSE PATIENT IMPACT. THE INSTRUMENT WAS INSPECTED BY MEDTRONIC FRANCE SERVICE AND REMAINS IN USE. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THE DETAILS OF THE EVENT WERE SUMMARIZED AS FOLLOWS: O T=0 NORMAL COAGULATION O BYPASS LASTED 165 MIN AND ACTIVATED CLOTTING TIME (ACT) WAS BETWEEN 430 AND 460 SECONDS DURING THAT TIME. BLOOD CLOTS APPEARED ON THE PERICARDIUM AND THE MEASURE OF ACT WAS 451, ANOTHER MEASURE OF ACT MADE WITH ANOTHER MACHINE AND GAVE ACT OF 456 SEC. O INJECTION OF 19000UI OF HEPARIN AND THE END OF THE PROCEDURE
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Patient 1
EVENT INVESTIGATION REMAINS IN PROGRESS AND THE INSTRUMENT REMAINS WITH THE CUSTOMER IN THE FIELD. HOWEVER, PRELIMINARY ANALYSIS PERFORMED IN THE FIELD SHOWED THAT THE DEVICE PERFORMED AS INTENDED. THERE WERE NO PRODUCT ISSUES OR MALFUNCTIONS DETECTED THAT WOULD HAVE IMPACTED THIS EVENT. PATIENT AND DEVICE INFORMATION HAS BEEN REQUESTED. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).
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Patient 1
THIS SUPPLEMENTAL REPORT IS SUBMITTED IN ORDER TO CORRECT THE INITIAL REPORT FROM A REPORTABLE SERIOUS INJURY TO A NON-REPORTABLE EV ENT. EVALUATION OF THIS PRODUCT EVENT INDICATES THAT THE DEVICE DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY. INFORMATION RECEIVED FROM THE FIELD INDICATES THAT THERE WAS NO PATIENT HARM AS A RESULT OF THIS PRODUCT EVENT. ADDITIONALLY, EVALUATION OF THE DEVICE EVENT DATA SHOWED THAT THE DEVICE PERFORMED AS EXPECTED, INDICATING NO MALFUNCTION. ADDITIONALLY, A REVIEW OF PRIOR EVENTS INDICATES THAT, FOR THIS PRODUCT OR SIMILAR PRODUCT, THE PRODUCT EVENT IS NOT SUSPECTED TO HAVE BEEN A CAUSE, OR CONTRIBUTORY CAUSE, OF ANY PREVIOUS INCIDENTS THAT HAVE LED TO DEATH OR SERIOUS INJURY. BASED ON THE INFORMATION ABOVE, MEDTRONIC CONCLUDED THAT THIS DEVICE DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY AND THE EVENT WOULD NOT LIKELY CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF IT WERE TO RECUR. (B)(4).