System 1000 family of Hemodialysis Instruments, including the System 1000, TINA, AURORA and AltraTouch; Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A. The Hemodialysis and Continuous Renal Replacement Therapy devices are used for acute and chronic hemodialysis, including high flux hemodialysis. The device is intended for use by trained operators when prescribed by a physician. The device is intended to be used with hollow fiber or parallel plate dialyzers.
This recall has been terminated (originally issued November 12, 2009).
- Company
- Baxter Healthcare Renal Div
- Recall Initiated
- August 31, 2009
- Posted
- November 12, 2009
- Terminated
- November 15, 2010
- Recall Number
- Z-0179-2010
- Quantity
- 8,258 units
- Firm Location
- Mc Gaw Park, IL
- Official Source
- View on FDA website ↗
Reason for Recall
When the main power is lost temporarily, a software anomaly prevents the instrument from automatically changing the ultrafiltration rate (UFR) to the minimum value as described in the Operator's manual.
Distribution
Worldwide Distribution -- United States (including Puerto Rico and the Virgin Islands), Algeria, Argentina, Austria, Bahrain, Bangladesh, Brazil, Bulgaria, Canada, Chile, China, Colombia, Croatia, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, Germany, Greece, Guatemala, Honduras, India, Indonesia, Ireland, Italy, Jordan, Korea, Latvia, Lebanon, Lithuania, Malaysia, Mauritania, Mexico, Morocco, Nigeria, Oman, Panama, Paraguay, Peru, Philippines, Poland, Romania, Russia, Saipan, Singapore, Slovakia, South Africa, Spain, Sweden, Taiwan, Thailand, Trinidad, Tunisia, Turkey, Ukraine, United Kingdom, Uruguay and Venezuela.
Lot / Code Info
All systems with 4.B.09, 4.B.1.1 and 4.B.1.3 software.
Root Cause
Software design
Action Taken
Baxter sent an Urgent Device Correction letter dated August 31, 2009 to all System 1000 Series of Hemodialysis Instruments customers via first class mail on the same date, to the attention of the Hemodialysis Administrator. The letters informed the accounts that a software anomaly in software versions 4.B.0.9, 4.B.1.1 and 4.B.1.3 was discovered when the main power was lost temporarily during a simulated treatment. The anomaly prevents the instrument from automatically changing the ultrafiltration rate (UFR) to the minimum value as described in the Operator's Manual. The accounts were informed that instruments with software versions 4.B.0.9, 4.B.1.1 and 4.B.1.3 will be upgraded to version 4.B.1.4 software, provided the instruments have a 486 Motherboard or Single Board Computer, and that instruments containing versions of 4.A software are not affected. The accounts were requested to complete the enclosed Customer Reply form, indicating the instrument serial number and software version for each machine at the site, and if they would be requesting Baxter Technical Services to upgrade their instruments or have the software sent to them to make the upgrades, and fax the sheet to 1-847-270-5457. Any questions were directed to Baxter Global Technical Services at 1-800-553-6898, prompt 4, option 1.