Recall Z-0179-2010 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Baxter Healthcare Renal Div
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 devi
| Date | Nov 12, 2009 (initiated Aug 31, 2009) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Software design |
| Action | 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 |
| Quantity | 8,258 units |
| 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, In |
| FDA record | Open on fda.gov |