Retiro De Equipo (Recall) de Device Recall System 1000, TINA, AURORA and Altratouch

Recall

34645

Class 2

Z-0766-06

2006-02-24

2006-04-18

Terminated

United States

2008-10-28

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=44321

The older style 'through hardware' dialysate monitoring manifolds and 'noryl' ultra filtration removal regulators may become cracked due to mechanical and thermal stress. if either of these parts become cracked during patient treatment, there is the potential for an ultrafiltration error to occur, which can result in excessive removal of fluid from the patient.

Baxter sent Urgent Device Correction letters dated 02/24/06 to all System 1000, TINA, Altratouch and Aurora Hemodialysis 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 for the older style 'Through Hardware' Dialysate Monitoring Manifolds and 'Noryl' Ultra Filtration Removal Regulators to become cracked due to mechanical and thermal stress. Color photographs of the old style and new style components were included in the letter. The accounts were informed that if the cracking occurs during patient treatment, the potential exists for an ultra filtration error to occur, which can result in excessive removal of fluid from the patient. Baxter provided a chart to determine which upgrade kit is required for each unit, based on the serial number involved. The accounts were requested to complete the enclosed Action Completion Response form, indicating the instrument serial number and which parts are needed for each machine at the site, and fax the sheet to 1-727-544-3025. Upon receipt of the Action Completion Reply form, a Baxter Field Service Engineer will call the account to schedule the upgrades. Any technical questions were directed to Baxter Global Technical Services at 1-800-553-6898, prompt 3, option 2, choice 1.