Device product
Sarns Centrifugal System Control module, 100/115V The Sarns Centrifugal System is indicated for use in cardiopulmonary bypass procedures only.
Z-0051-2013
Product summary
- Event
- Event 62059
- Status
- Terminated
- Classification
- Class II
- Quantity
- 847 units
- Official record key
device-enforcement:Z-0051-2013
Official wording
Reason: Terumo Cardiovascular Systems (Terumo CVS) received one report of loss of power to the control module and subsequently the drive motor for the Sarns centrifugal system during cardiopulmonary bypass.
Code information: Catalog number: 6379 and serial numbers: 942,1003-1006,1034,1039,1051,1056,1087,1914,3030,4019,4344, 5009,5012,5013,5030,5048,5059, 5062, 5080, 5096, 5111, 5112, 5122, 5140, 5713, 6003, 6005, 6023, 6024, 6027, 6033, 6034, 6054, 6055, 6060, 6066, 6068, 6069, 6073, 6079, 6081, 6082, 6086, 6089, 6090-6092, 6097, 6107, 6109, 6112, 6119, 6126-6128, 6236, 6379, 7000-7785, and R7051.
Distribution pattern: Worldwide Distribution - USA (nationwide) and the countries of Bangladesh, Seoul Korea, Chile, Brazil, Venesuela, Thailand, Mexico, India, Taiwan, Canada, Dominican Republic, Guatemala, Ecuador, Germany, Republic of Georgia, Hong Kong, Japan, United Arab Emirates (UAE), Japan, Belgium, Phillipines, Singapore, and South Africa.
Derived failure modes
-
Unknown
Terumo Cardiovascular Systems (Terumo CVS) received one report of loss of power to the control module and subsequently the drive motor for the Sarns centrifugal system during cardiopulmonary bypass.