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U.S. Department of Health and Human Services

Class 2 Device Recall Baxter System 1000 Hemodialysis Systems

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  Class 2 Device Recall Baxter System 1000 Hemodialysis Systems see related information
Date Initiated by Firm June 14, 2005
Date Posted August 24, 2005
Recall Status1 Terminated 3 on February 26, 2008
Recall Number Z-1394-05
Recall Event ID 32322
510(K)Number K970446  
Product Classification Device, Hematocrit Measuring - Product Code JPI
Product Baxter System 1000 Single Patient Hemodialysis Systems, product codes SYS1000L3, SYS1000L3P, SYS1000L3T, SYS1000L3TD, SYS1000L2C2; Baxter Healthcare Corporation, Renal Division, McGaw Park, IL 60085
Code Information 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		 Operator's Manuals addenda are being issued to provide correct information concerning the correct syringe size to use for heparin infusion, the use of chemical disinfectants in the System 1000, TMP Advise, and Bicarbonate Value calculations.
FDA Determined
Cause 2		 Other
Action Baxter sent Important Product Information letters dated 6/14/05 to all System 1000 and Arena Hemodialysis customers, to the attention of the Hemodialysis Administrator, via first class mail. Enclosed with the letter were copies of addenda to the Operator''s Manual for both the System 1000 and Arena instruments. The letter informed the accounts of the following problems: a) Improper Syringe Size - it is important to use the correct syringe size for heparin infusion to avoid improper infusion of heparin. The warning 'Ensure the instrument is properly configured for the type and size of heparin pump syringe being installed.' was added to the manual under the Priming the Dialyzer and Blood Lines section of Operation. b) Disinfection Infusion Monitor (System 1000 only) - Procedural steps have been added to the System 1000 manual to confirm the level in the disinfectant bottle prior to and after chemical disinfection to ensure that disinfection fluid has been utilized during the disinfection cycle. c) TMP Advise - the 'TMP Alarm in Dialyzer Mode' section in both the System 1000 and Arena manuals has been removed. d) Bicarbonate Value - the Dialysate Preparation section of the manual was revised to clarify the bicarbonate display of the System 1000 and Arena instruments. Any questions were directed to Baxter Global Technical Services at 1-800-553-6898.
Quantity in Commerce 14,917 units
Distribution Nationwide and internationally to Argentina, Australia, Belgium, Brazil, Canada, Chile, China, Colombia, India, Indonesia, Korea, Mexico, Peru, Philippines, Singapore, Spain, Switzerland, Taiwan, Thailand and Turkey.
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 = JPI and Original Applicant = ALTHIN MEDICAL AB AN AFFILIATE OF BAXTER INTL
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