System, Dialysate Delivery, Sealed
FDA adverse event reports and recall history for system, dialysate delivery, sealed (product code FII), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 3,214
- Deaths
- 149
- Injuries
- 666
- Malfunctions
- 1,997
Reports per year
Source: FDA adverse event reports by year received, 1999–2014. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2004-12-24TerminatedOther
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.
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.
- 2004-07-20TerminatedOther
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
These devices have the potential to overheat in the absence of a Ground Fault Circuit Interrupter (GFCI). This heater system failure could result in a fire.
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