Device Recall Baxter System 1000 Hemodialysis Systems 의 리콜

Recall

32322

Class 2

Z-1394-05

2005-06-14

2005-08-24

Terminated

United States

2008-02-26

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=39626

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.

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.