Recall Z-0367-05 ยท FII System, Dialysate Delivery, Sealed
Baxter Healthcare Renal Div
System 1000 family of Hemodialysis Instruments, including the System 1000, Arena, 1550, BM11, BM25 and Meridian; Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A.
| Date | Dec 24, 2004 (initiated Dec 14, 2004) |
| Status | Terminated |
| Reason | Air bubbles have been observed in the tubing sets past the air detector of the instrument with no alarms. Air bubbles in the circuit can cause an air embolism. |
| Root cause | Other |
| Action | An Urgent Device Correction letter dated 12/14/04 was sent along with a reply form and addenda to operator''s manuals to all Baxter customers who have purchased hemodialysis hardware. The letter informed the accounts of reports of air bubbles observed in the tubing sets past the air detector without an alarm alerting the operator of potential air in the tubing. A review of the reports revealed misuse, including failure to follow generally observed hemodialysis practices. Baxter updated their Hemodialysis Operator''s Manuals and Training Guides to clarify instructions and add caution and warni |
| Distribution | This action covers Baxter''s complete line of hemodialysis hardware, which was distributed nationwide, including Puerto Rico, and internationally to Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Denmark, Ecuador, Finland, France, Republic of Georgia, Greece, Guatema |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K030099 | BAXTER ARENA HEMODIALYSIS DELIVERY SYSTEM, MODEL 1571278000 Baxter Healthcare Corp, Jun 17, 2003 |
| K872364 | HEMODIALYSIS (SPS), MODEL 550, CODE 5M1309 Travenol Laboratories, S.A., Oct 13, 1987 |
| K894838 | HEMODIALYSIS SINGLE PATIENT SYSTEM (SPS) 550 VSB Baxter Healthcare Corp, Sep 7, 1989 |
| K970446 | DRAKE WILLOCK SYSTEM & ALTRA TOUCH 1000 DIALYSIS DELIVERY SYSTEM Althin Medical AB an Affiliate of Baxter Intl, Jun 2, 1997 |