FDAnews Device Daily Bulletin


Nov. 16, 2005

Baxter Healthcare has announced that it will voluntarily withdraw its 6060 Multi-Therapy Infusion Pump from the market over the next year, based on concerns with the device short-circuiting and other flaws that have resulted in either too much medication being delivered or interruption of therapy.

In a recent letter to customers, the company warned that it had discovered overinfusions that had resulted in one death and two serious injuries. Baxter identified that a frayed cord or fluid ingress into the device created a short circuit that simulated the repeated pressing of a button requesting medication. The company also found instances where infusion unexpectedly stopped without an alarm or malfunction code. However, Baxter said that the probability of occurrence of these issues is remote.

The pump is used to deliver pain management medications in the Patient Controlled Analgesia profile, as well as in administering critical medications.

The pump was developed by Sabratek and acquired by Baxter in 2000, and approximately 34,000 pumps are currently in use worldwide, including 30,000 in the United States. Anticipated worldwide sales for 2005 of the 6060 pump and related disposable sets are approximately $15 million.

Baxter has communicated its decision to the FDA, and the company will be working with customers on a transition plan.