• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Enforcement Report - Week of November 21, 2012

  • Print
  • Share
  • E-mail
-

Event Detail

Event ID 63344
Product Type Devices
Status Ongoing
Recalling Firm Terumo Cardiovascular Systems Corporation
City Ann Arbor
State MI
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-10-16
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern Nationwide Distribution including CA, HI, KS, LA, MI, MO, OR, PA, UT, and WI

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
HX2 Temp Manage SYS 120V 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. Catalog number: 809810 and serial numbers: 1041, 1083, 1084, and 1101-1116. Class II 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, not during a procedure. When a failure occurred at start-up, the clinicians mitigated the failure by shutting down the devices and using a back-up system as recommended in the user's manual. 19 units Z-0278-2013
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. Catalog number: 817168 and serial numbers: 824POOO023, 831 P001130, 831 P001133, 831 P001136, 831 P001140, 831 POO1141 , 831 P001144, 831 P001145, 831 P001146, 831 P001149, 831 P001151, 831 P001159, 831P001161, 831P001164, and 836POOOO05. Class II 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, not during a procedure. When a failure occurred at start-up, the clinicians mitigated the failure by shutting down the devices and using a back-up system as recommended in the user's manual. 15 units Z-0279-2013
-
-