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Patient 1
THE PRODUCTION DEVICE HISTORY RECORD (DHR) FOR THIS INTRA-AORTIC BALLOON PUMP (IABP) WAS NOT REQUIRED TO BE REVIEWED AS PER COMPANY STANDARD OPERATING PROCEDURE SINCE THE DEVICE MANUFACTURE DATE IS GREATER THAN ONE YEAR FROM THE EVENT DATE. (B)(6). THE GETINGE FIELD SERVICE ENGINEER (FSE) THAT ENCOUNTERED THE ISSUE SUSPECTED LEAKS FROM FILL MANIFOLD AND THEN DRIVE MANIFOLD, SO BOTH WERE REPLACED. THE FSE REPLACED THE DRIVE MANIFOLD PRESSURE TRANSDUCER SUSPECTING THAT A FALSE READING WAS BEING SENT. THE FSE FOUND THAT THE SOLENOID COULD BE MANUALLY MANIPULATED TO DRAW VACUUM AND THAT K10 WAS NOT FUNCTIONING CORRECTLY DURING VACUUM AND PRESSURE STAGES. THE FSE REPLACED THE SOLENOID CONTROL BOARD AND REMEDIED THE ISSUE. THE FSE THEN PERFORMED AND COMPLETED A PREVENTIVE MAINTENANCE WITH ALL CALIBRATION, FUNCTIONAL AND SAFETY CHECKS TO MEET FACTORY SPECIFICATIONS. UNIT PASSED ALL CALIBRATION, FUNCTIONAL AND SAFETY TEST PER FACTORY SPECIFICATIONS. THE IABP WAS THEN RELEASED TO THE CUSTOMER AND CLEARED FOR CLINICAL SERVICE.