Tested AC Control BD, 120V, X2 The Terumo HX2 Temperature Management System is a selfcontained, dual channel system for supplying temperature controlled water to heat exchangers used in an extracorporeal circuit.
Recall
- Recall Number
- Z-0279-2013
- Event Number
- 63344
- Firm
- Terumo Cardiovascular Systems Corporation
- FEI Number
- 1828100
- Product Code
- DWC
- Status
- Terminated
- Root Cause
- Nonconforming Material/Component
- Initiated
- October 16, 2012
- Posted
- November 13, 2012
- Terminated
- July 11, 2013
- Address
- 6200 Jackson Road, Ann Arbor, MI, 48103-9586
Description
Tested AC Control BD, 120V, X2 The Terumo HX2 Temperature Management System is a selfcontained, dual channel system for supplying temperature controlled water to heat exchangers used in an extracorporeal circuit.
Based on a retrospective review of quality data, AC Control boards used in the manufacture of the HX2 Temperature Management System were identified as being manufactured using the incorrect flux material. Use of the incorrect flux may contribute to premature board failure. A search of TCVS complaints revealed 3 complaints received related to the HX2 failure. Each failure occurred during set up
TERUMO sent an Urgent Medical Device Recall letter dated October 15, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Terumo has determined that a field correction is required to notify affected customers that the boards may fail, instruct the users that in a case of failure to swich to the second channel on the device or use a back-up unit, and that TCVS will replace the affected boards. Customers with questions were instructed to call 1-800-621-2818. For questions regarding this recall call 734-741-6173.
Nationwide Distribution including CA, HI, KS, LA, MI, MO, OR, PA, UT, and WI
15 units