CARDIOSAVE HYBRID, TYPE B PLUG

Description of Event or Problem

It was reported by customer that during use, the CARDIOSAVE Intra-Aortic Balloon Pump (IABP) had a helium leak. The leak was located externally. The customer stated that tubing disconnected from the safety disk and unit was swapped after it was unable to be reset. No patient harm or injury reported. A Getinge Field Service Engineer (FSE) evaluated the unit for the reported malfunction. The FSE was unable to duplicate the issue, exercised unit to no fail. However, the alarm log revealed multiple alarms: IAB Catheter Restriction, IAB Disconnected, and Autofill Failure. Transducers and regulators were calibrated. Product passed all functional and safety tests per manufacturer specifications.