Baxter Meridian Hemodialysis

The Baxter Meridian is a single patient hemodialysis instrument that prepares dialysis solution, circulates blood through an external tubing system and hemodialyzer, and monitors the system for operating conditions.

There have been reports of hemolysis (broken blood cells) related to kinks in the blood tubing sets used with the Baxter Meridian. To date, there have been reports of at least one death and one serious injury, associated with kinking of blood tubing sets routed through both channels of the two channel clips mounted on the front of the Baxter Meridian. The original labeling for the device is inadequate because it instructs users to route the blood tubing sets through both channels of the two-channel clips.

• Baxter notified its customers of the problem in an "Urgent Product Recall" letter dated September 28, 2005 . FDA classified this action as a Class I Recall. Class I recalls are the most serious types of recalls and involve situations in which there is a reasonable probability that use of the effected product may cause serious injury or death if the problem is not corrected.
• This classification does not require the return of Baxter Meridian instruments currently in the market.
• In the September 28, 2005, notification regarding the Baxter Meridian Hemodialyis (HD) Instrument, Baxter directed customers to route blood tubing through only one channel of the two channel clips mounted on the front of the Baxter Meridian to reduce the risk of blood tubing kinks. Baxter's letter to customers is available on its web site at http://www.baxter.com.
• Baxter provided labels with the September 28, 2005, notification to be affixed to Baxter Meridian instruments. The labels display the proper routing of the blood tubing sets through the two channel clips. Further, Baxter asks that all care providers be trained and that they follow the proper set up and use only one of the two channels of the two channel clips during treatment. Continuous verification through visual inspection of the tubing will reduce the chances of kinking. In addition, Baxter will be providing modified tubing clips to eliminate related safety issues as soon as possible.

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