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U.S. Department of Health and Human Services

Class 2 Device Recall System 1000, TINA, AURORA and ARENA Hemodialysis Instruments

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  Class 2 Device Recall System 1000, TINA, AURORA and ARENA Hemodialysis Instruments see related information
Date Initiated by Firm November 18, 2005
Date Posted January 06, 2006
Recall Status1 Terminated 3 on March 04, 2008
Recall Number Z-0347-06
Recall Event ID 34043
510(K)Number K030099  K013562  K910215  
Product Classification Dialyzer, High Permeability With Or Without Sealed Dialysate System - Product Code KDI
Product System 1000 family of Hemodialysis Instruments, including the System 1000, TINA, AURORA and ARENA; Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A.
Code Information product codes S1000L3, S1000L3P, S1000LC2, S1000L3T, S1000L3TD, S1000L3PR, ARENASP, ARENASPP, ARENASPX, ARENADPX; all serial numbers
Recalling Firm/
Manufacturer		 Baxter Healthcare Renal Div
1620 Waukegan Rd Bldg R
Mc Gaw Park IL 60085-6730
For Additional Information Contact Center for One Baxter
800-422-9837
Manufacturer Reason
for Recall		 Potential for fluid or air to be passed through the venous line clamp if the tubing is not centered in the clamp and extends beyond the edge of the clamp's pinch zone. This could result in an air emboli condition.
FDA Determined
Cause 2		 Other
Action Baxter sent Urgent Device Correction letters dated 11/18/05 to all System 1000, TINA, Aurora and Arena Hemodilaysis Instrument customers via first class mail on the same date, to the attention of the Hemodialysis Administrator. The letters informed the accounts that the potential exists for fluid or air to be passed through the venouus line clamp that could result in an air emboli condition. This condition can occur when the tubing is not centered on the clamp and extends beyond the edge of the clamp''s pinch zone. Baxter will make arrangements to upgrade the instruments with either a linear or rotary venous line clamp upgrade as soons as they become available within the next three months. The letters included copies of a diagram showing the correct and incorrect placement of the tubing in the clamp, and a Technical Service Bulletin that provided an adjustment procedure to perform an interim correction to the linear line clamp configuration prior to the upgrade. Any questions regarding the execution of this procedure were directed to Baxter Global Technical Services at 1-800-553-6898.
Quantity in Commerce 29,173 machines
Distribution Nationwide and internationally to Canada, Korea, Hong Kong, Shanghai, Jamaica, Philippines, United Kingdom, Denmark, India, Belgium, Mexico, Italy, Austria, Sweden, Ecuador, Argentina, Brazil, Chile, Colombia, Peru, Turkey and Australia.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = KDI and Original Applicant = BAXTER HEALTHCARE CORP.
510(K)s with Product Code = KDI and Original Applicant = CD MEDICAL, INC.
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