Terumo Cardiovascular Systems Corporation: 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.; 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.

Agency Publication Date: October 11, 2012

Affected Products

Product: Sarns Centrifugal System Control module, 100/115V The Sarns Centrifugal System is indicated for use in cardiopulmonary bypass procedures only.

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.

Product: Sarns Centrifugal System Control module, 220/240V The Sarns Centrifugal System is indicated for use in cardiopulmonary bypass procedures only.

Catalog number: 6380 and serial numbers: 5007, 5028-5030, 5032, 5075, 5076, 5135,6010,6013,6025,6030,6116, 7000-7197,7372, and 7373.

Product: Sarns Centrifugal System Control module System 9000 The Sarns Centrifugal System is indicated for use in cardiopulmonary bypass procedures only.

Catalog number: 6381 and serial numbers: 1003-1006, 1020, 1026, 1045, 2001, 2017,2018,2036,7000-7113, and 7381.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 62059

Status: Resolved

Manufacturer: Terumo Cardiovascular Systems Corporation

Manufactured In: United States

Units Affected: 3 products (847 units; 213 units; 126 units)

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Sources: FDA iRES · Raw API Response

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