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BY OUR PHARMA CORRESPONDENT
23 July, 2005: The United States Food and Drug Administration (US FDA) recalled 206,000 pumps that deliver medicines intravenously to patients following the deaths of three people.
The deaths occurred due to the unexpected closure of the infusion pumps while administering medicines, the federal drug regulator said in an announcement.
Colleague volumetric infusion pumps made by Baxter International shut down for a variety of software, wiring and design reasons. One of the most basic problems is that the "On/Off" key is so close to the "Start" key that nurses may inadvertently turn the machines off when they actually intend to begin drug therapy, the agency said.
However, FDA is not ordering all such devices to be sidelined as some hospitals depend entirely on the pumps. Instead, the agency is asking hospitals and other users to employ other machines in critical care cases if possible, and to monitor the machines closely.
The agency termed the recall Class 1, its most serious classification and one that involves "a reasonable probability that using the affected product will cause serious injury or death."
Sources from Baxter International said that the company sent a letter in March to its customers warning of problems with the infusion pumps.
Baxter is a specialty pharmaceutical and device company based in Deerfield,
Illinois, USA.
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