System 1000 family of Hemodialysis Instruments, including the System 1000, TINA, AURORA and Altratouch; Baxter Healthcar

FDA device recall Z-0766-06 · posted 2006-04-18 · Terminated

Recall details

Recalling firm

Baxter Healthcare Renal Div

Reason for recall

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.

Action taken

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.

Root cause

Other

Status

Terminated

Product code

FKP

Quantity affected

14,917 units

Distribution

Nationwide including Puerto Rico, and internationally to Algeria, Austria, Bahrain, Belgium, Bulgaria, Croatia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Ireland, Israel, Italy, Jordan

Date initiated

2006-02-24

Date posted

2006-04-18

Date terminated

2008-10-28

Location

Park, IL

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