Recall Z-0833-03 ยท FKP System, Dialysate Delivery, Single Patient
Baxter Healthcare Corp.
Baxter System 1000 Single Patient Hemodialysis Delivery System; Model SYS1000; all series 1000 instruments labeled as System 1000, AltraTouch 1000, Baxter Tina and Baxter Aurora; Baxter Healthcare Corporation, Deerfield, IL 60015 USA or Baxter Healthcare Corporation, McGaw Park, IL 60085 USA
| Date | May 15, 2003 (initiated Mar 20, 2003) |
| Status | Terminated |
| Reason | The dialysis treatment may be run without the bicarbonate due to an undetected bicarbonate pump stall following a sodium change. |
| Root cause | Other |
| Action | Baxter sent recall letters dated 3/20/03 to the Medical Director and Hemodialysis Chief Technicians via first class mail on 3/20/03. The letters informed the accounts of the potential of running a treatment without bicarbonate due to an undetected bicarbonate pump stall following a sodium change, and provided instructions to change the B-A-alarm limits on the System 1000 Delivery Systems and confirm proper functionality after completing these changes. These changes will prevent undetected acid-only delivery in the event of a sodium level change |
| Quantity | 25,014 units |
| Distribution | The devices were distributed nationwide and internationally to Baxter subsidiaries in Argentina, Belgium, Bolivia, Brazil, Canada, Chile, China, Ecuador, Egypt, El Salvador, Guatemala, Honduras, Hong Kong, India, Mexico, Philippines, Singapore, South Korea, Thailand, Turkey, United Kingdom, Venezuel |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K910215 | DRAKE WILLOCK SYSTEM 1000 DIALYSATE DELIVERY SYST Cd Medical, Inc., Apr 9, 1991 |