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

Enforcement Report - Week of October 17, 2012

  • Print
  • Share
  • E-mail
-

Event Detail

Event ID 63079
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 2012-09-25
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern Worldwide distribution: USA including AK, AL, AR, AZ, CA, CO, CT, DC

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Battery, 220V (Includes charger and connecting cable) The Sarns" Centrifugal System is indicated for use in cardiopulmonary bypass procedures only. Catalog number: 9491; and lot numbers: 1001-1187, 1101, 1193-1286, 2083-2085, 2018, 2288, 2289, 2447-2451, 2634, 2635, and 2884. Class II Terumo Cardiovascular Systems (Terumo CVS) has received multiple reports since 2004 of various malfunctions of the battery backup system for the Sarns" Centrifugal System. The reports can be broadly categorized as follows: " Failure to charge " Failure to hold charge " Failure to operate In the most severe case, a battery malfunction could result in an unexpected loss of arterial flow. In this case, if the user doesn't clamp the venous line quickly enough, the patient could experience hypovolemia. In the event of a backflow condition, air could become entrained in the arterial line, which if not detected, could be passed to the patient. 289 units Z-0050-2013
Battery, 100/115V (Includes charger and connecting cable) The Sarns" Centrifugal System is indicated for use in cardiopulmonary bypass procedures only. Catalog number: 9490; and lot numbers: 0101,1001-1025,1188-1192,1997, 2000-2017, 2019- 2082, 2086-2287, 2290-2446, 2452-2633, 2636-2938, and 2946-3063 Class II Terumo Cardiovascular Systems (Terumo CVS) has received multiple reports since 2004 of various malfunctions of the battery backup system for the Sarns" Centrifugal System. The reports can be broadly categorized as follows: " Failure to charge " Failure to hold charge " Failure to operate In the most severe case, a battery malfunction could result in an unexpected loss of arterial flow. In this case, if the user doesn't clamp the venous line quickly enough, the patient could experience hypovolemia. In the event of a backflow condition, air could become entrained in the arterial line, which if not detected, could be passed to the patient. 1076 Z-0049-2013
-
-