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U.S. Department of Health and Human Services

Class 2 Device Recall Baxter Arena Hemodialysis Delivery System

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  Class 2 Device Recall Baxter Arena Hemodialysis Delivery System see related information
Date Initiated by Firm February 20, 2004
Date Posted July 20, 2004
Recall Status1 Terminated 3 on February 26, 2008
Recall Number Z-0584-04
Recall Event ID 28375
510(K)Number K030099  
Product Classification Dialyzer, High Permeability With Or Without Sealed Dialysate System - Product Code KDI
Product Baxter Arena Hemodialysis Delivery System; Baxter Healthcare Corporation, Renal Division, McGaw Park, IL 60085 U.S.A.
Code Information Serial numbers 300001 through 300147
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		 These devices have the potential to overheat in the absence of a Ground Fault Circuit Interrupter (GFCI). This heater system failure could result in a fire.
FDA Determined
Cause 2		 Other
Action Baxter sent urgent device correction letters dated 2/20/04 to the Hemodialysis Unit Administrators on the same date. The letters informed the accounts of the potential of a heater system failure that under specific conditions could lead to a fire. The letters listed the concurrent conditions that must exist for the potential overheating, and recommended that the following steps be taken to ensure the safety in operating the devices: 1) Plug these machine into GFCI outlets if available, and 2) If GFCI outlets are not available at the facility, the machines must be 'hard-powered off' after dialysis treatments are complete at the end of the day. The machine is had-powered off by placing the main power switch located in the back of the machine into the OFF position. If the facility typically performs a heat clean cycle of machines after treatments are completed, it is imperative that the machines are hard powered off at the completion of the cycle. Any questions were directed to Baxter Instrument Services at 1-800-553-6898, select prompt 3, option 2 and choice 1, Monday through Friday, 8:30 AM to 6:00 PM EST.
Quantity in Commerce 130 units
Distribution The devices were distributed nationwide and internationally to Baxter subsidiaries in Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Denmark, Ecuador, Finland, France, Republic of Georgia, Greece, Guatemala, Honduras, Hong Kong, India, Indonesia, Ireland, Israel, Italy, Lebanon, Morocco, Malaysia, the Netherlands, Oman, Panama, Preu, Philippines, Poland, Palestine, Romania, Russia, Saudi Arabia, Singapore, Slovakia, South Korea, Spain, Sweden, Taiwan, Thailand, Tunisia, Turkey and United Kingdom.
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.
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