Description of Event or Problem · 0
ON 14 MARCH 2012, MEDTRONIC PERFUSION SYSTEMS RECEIVED INFORMATION THAT DURING USE IN A PERCUTANEOUS CARDIOPULMONARY SUPPORT (PCPS), THE KYOCERA GYRO PUMP WAS RUN AT 4100 RPM, AND LATER AT SPEEDS OF UP TO 4330 RPM. THE CUSTOMER HAD BEEN NOTIFIED THAT THE MAXIMUM RPM OF THE GYRO PUMP WAS 4000 RPM. AFTER APPROXIMATELY ELEVEN HOURS OF USE, IT WAS NOTED THAT THE GYRO WAS MAKING A "RASPING SOUND", AND AFTER APPROXIMATELY TWELVE HOURS THE GYRO PUMP WAS REPLACED. THE APPROXIMATE BLOOD LOSS FROM CHANGING THE GYRO PUMP WAS 60CC. AFTER CHANGING OUT THE GYRO PUMP, THE REPLACEMENT UNIT WAS RUN AT LESS THAN 4000 RPM AND NO FURTHER NOISE WAS NOTED. THERE WERE NO ADVERSE PATIENT EFFECTS AS A RESULT OF THE NOISE. THE PRODUCT WAS RETURNED TO KYOCERA FOR ANALYSIS. (B)(4). THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).