SARNS 8000 MODULE PERFUSION SYSTEM

Additional Manufacturer Narrative

(B)(4). THE FIELD SERVICE REPRESENTATIVE WAS DISPATCHED TO THE USER FACILITY. HE PERFORMED FUNCTIONAL TESTING OF THE AIR BUBBLE DETECTOR (ABD) ALSO KNOWN AS THE ULTRASONIC AIR SENSOR (UAS). THE FSR COULD NOT DUPLICATE ANY PROBLEMS. THE SYSTEM MET MANUFACTURERS SPECIFICATIONS AND WAS RETURNED TO CLINICAL USE.

Description of Event or Problem

IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE AIR BUBBLE DETECTOR (ABD) INFORMATION WOULD NOT POPULATE ON THE MONITOR OF THE HEART LUNG MACHINE. THE PERFUSIONIST COULD NOT RESET THE ABD TO TURN IT "ON". WHEN SHE TURNED IT "ON" WITHOUT GOING THROUGH RESET BUTTON IT WOULD STOP THE ARTERIAL PUMP HEAD. THEREFORE, THE SURGERY WAS INITIATED WITHOUT UTILIZING AN ABD. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO DELAY, NO BLOOD LOSS, NOR ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION OBTAINED: THE ABD WAS LOCATED BETWEEN THE VENOUS RESERVOIR AND THE ARTERIAL ROLLER PUMP IN AN OPERATING ROOM THAT WAS VERY COLD (AROUND 58 DEGREES FAHRENHEIT). THE LATCH ON THE ABD SEEMED MORE DIFFICULT THAN NORMAL TO CLOSE BUT THERE WERE NO VISUAL SIGNS OF DAMAGE. THE PERFUSIONIST ACTIONS TO TROUBLE SHOOT WERE TO DISCONNECT THE POWER CORD FROM THE CONTROL BOX AND ALSO FROM THE ABD. SHE TURNED OFF THE CONTROL BOX AND ALLOWED IT TO REBOOT. SHE CLEANED THE ABD SENSOR AND RED BOX WITH ALCOHOL SWABS. HOWEVER, SHE COULD NEVER GET IT TO "RESET" AND THEREFORE BE ABLE TO TURN IT ON.

Additional Manufacturer Narrative

THE REPORTED COMPLAINT WAS NOT CONFIRMED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE ON THIS COMPLAINT THAT WOULD ALTER THE FACTS AND/OR CONCLUSION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.