Device product
CARDIOSAVE Intra-Aortic Balloon Pump and CS300 Intra-Aortic Balloon Pump; and, non-sterile, not for human use, SENSATION and SENSATION PLUS IABC demonstration units. Part Number 0998-00-0800-xx; 0998-00-3023-xx; 0998-UC-0800-xx; 0998-UC-3023-xx An electromechanical system used to inflate and deflate intra-aortic balloons.
Z-1062-2015
Product summary
- Event
- Event 69863
- Status
- Terminated
- Classification
- Class II
- Quantity
- 838 units-US; 364 units - OUS
- Official record key
device-enforcement:Z-1062-2015
Official wording
Reason: Ferrule Cap was not removed on some fiber-optic Sensation and Sensation Plus IABC demonstration units. If fiber-optic connector is inserted into the Maquet CS300 or CARDIOSAVE IABP, cap will prevent connection of unit and may become dislodged and remain in IABPs fiber-optic receptacle.
Code information: Sensation 7 fr.34 cc IAB Demonstration Unit 0684-DC-0433 0684-DO-0433 0684-DC-0469 0684-DO-0469 Sensation 7 Fr. 40 cc IAB Demonstration Unit 0684-DC-0434 0684-DO-0434 0684-DC-0470 0684-DO-0470 Sesnsation Plus 7.5 Fr. 40cc IAB Demonstration Units 0684-DC-0567 0684-DO-0567 0684-DC-0568 0684-DO-0568 Sensation Plus 7.5 Fr. 50cc IAB Demonstration Units 0684-DC-0575 0684-DO-0575 0684-DC-0576 0684-DO-0576 Sensation Plus 8 Fr. 50 cc IAB Demonstration Unit 0684-DC-0272 0684-DO-0272
Distribution pattern: Worldwide Distribution
Derived failure modes
-
Unknown
Ferrule Cap was not removed on some fiber-optic Sensation and Sensation Plus IABC demonstration units. If fiber-optic connector is inserted into the Maquet CS300 or CARDIOSAVE IABP, cap will prevent connection of unit and may become dislodged and remain in IABPs fiber-optic receptacle.