Hospitals urged to monitor Baxter infusion pumps

Baxter Healthcare Corp. has received a second Food & Drug Administration Class 1 recall in less than four months for its Colleague Volumetric Infusion Pumps. The FDA's Sept. 19 recall relates to pump battery excessive discharge and swelling failures, which cause the devices to become incapable of operating on battery power for the expected amount of time. This leads to interruption or prevention of therapy and possible death or injury. Baxter said it has received reports from customers that the problem may have been associated with four deaths and 10 serious injuries.

On July 19, 2005, the FDA issued a Class 1 recall for an unrelated problem associated with a design issue that generates failure codes and causes the pump to stop. The FDA said Baxter informed the agency that the pump's inadvertent stoppage resulted in six reports of serious injury and three reports of death. And "in addition to the shut-down problem, the device may exhibit two additional failure modes: Users may inadvertently press the on/off key instead of the start key when attempting to start an infusion. Also, disconnecting or connecting the pump from the hospital monitoring system while the pump is powered 'on' can result in a failure code, requiring the infusion to be restarted," said FDA.

About 206,000 Colleague pumps are in use in the United States and another 49,000 worldwide. The company stopped shipping the pumps earlier this year as a result of issues related to the July recall. The Colleague battery-related problems go back at least four years. On Jan. 21, 2003, Baxter issued an Important Product Information letter to customers noting the swelling problem. And in September 2001, the company issued a battery-interface software upgrade to address battery problems in some models. In a July 21, 2005, news release announcing the design-related failure code issues, Baxter cited still another problem: "In a separate field corrective action letter sent to customers today, the company announced it is developing an aggressive action plan to address a design issue ... involv(ing) a clocking circuit contained in the pump that can disrupt internal communications in some devices. While the incidence of this occurring is low, when it does occur, the pump alarms, the infusion stops, and the pump displays a failure code. The FDA has been informed of this action and has not yet classified this recall."

The issues may be particularly trying for health-system R.Ph.s, said Michael R. Cohen, R.Ph., president of the Institute for Safe Medication Practices. The pumps are popular, and every model of infusion pump is different. If a pump needs to be replaced with another model, personnel may need to be retrained, and safety issues can become a major undertaking. The FDA and Baxter are instructing hospitals to correct the problem on existing devices and not return the pumps. "We are not pulling our pumps out of the field," said Cindy Resman, spokeswoman for the Deerfield, Ill., manufacturer.

The company has advised putting a harness around the battery to help prevent the swelling and has implemented an aggressive program of notifying hospitals of the warning signs associated with a battery malfunction, she said. Company officials also informed hospitals that when batteries become excessively discharged, the battery charge level indicator will overstate the amount of battery charge remaining. Baxter officials said it would provide software updates to address the issue of damage from excessive battery discharge. It is also modifying the design of the infusion pump software to reduce the possibility of inadvertent powering-off at the start of an infusion and to make the pump more "fault-tolerant."

ECRI, a nonprofit health research firm that monitors medical-device safety issues, said Baxter's remedial steps are acceptable to date. "We have studied the issues related to the pumps very thoroughly," said Mark Bruley, ECRI's VP for accident and forensic investigation. "We believe the dangers inherent in pump replacement may well outweigh those inherent in the Colleague's ongoing problems."