Baxter System 1000 Single Patient Hemodialysis Systems, product codes SYS1000L3, SYS1000L3P, SYS1000L3T, SYS1000L3TD, SY
FDA device recall Z-1394-05 · posted 2005-08-24 · Terminated
Recall details
- Recalling firm
- Baxter Healthcare Renal Div
- 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.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- JPI
- Quantity affected
- 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, Thai
- Date initiated
- 2005-06-14
- Date posted
- 2005-08-24
- Date terminated
- 2008-02-26
- Location
- Park, IL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DRAKE WILLOCK SYSTEM & ALTRA TOUCH 1000 DIALYSIS DELIVERY SYSTEM (K970446) | Althin Medical AB an Affiliate of Baxter Intl | 1997-06-02 |