System 1000 family of Hemodialysis Instruments, including the System 1000, TINA, AURORA and ARENA; Baxter Healthcare Cor

FDA device recall Z-0347-06 · posted 2006-01-06 · Terminated

Recall details

Recalling firm

Baxter Healthcare Renal Div

Reason for recall

Potential for fluid or air to be passed through the venous line clamp if the tubing is not centered in the clamp and extends beyond the edge of the clamp's pinch zone. This could result in an air emboli condition.

Action taken

Baxter sent Urgent Device Correction letters dated 11/18/05 to all System 1000, TINA, Aurora and Arena Hemodilaysis 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 exists for fluid or air to be passed through the venouus line clamp that could result in an air emboli condition. This condition can occur when the tubing is not centered on the clamp and extends beyond the edge of the clamp''s pinch zone. Baxter will make arrangements to upgrade the instruments with either a linear or rotary venous line clamp upgrade as soons as they become available within the next three months. The letters included copies of a diagram showing the correct and incorrect placement of the tubing in the clamp, and a Technical Service Bulletin that provided an adjustment procedure to perform an interim correction to the linear line clamp configuration prior to the upgrade. Any questions regarding the execution of this procedure were directed to Baxter Global Technical Services at 1-800-553-6898.

Root cause

Other

Status

Terminated

Product code

KDI

Quantity affected

29,173 machines

Distribution

Nationwide and internationally to Canada, Korea, Hong Kong, Shanghai, Jamaica, Philippines, United Kingdom, Denmark, India, Belgium, Mexico, Italy, Austria, Sweden, Ecuador, Argentina, Brazil, Chile,

Date initiated

2005-11-18

Date posted

2006-01-06

Date terminated

2008-03-04

Location

Park, IL

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