NYT: F.D.A. Orders (Class 1) Recall of Intravenous Pumps

[DeepModem Mom]

F.D.A. Orders Recall of Intravenous Pumps
By GARDINER HARRIS
Published: July 22, 2005


WASHINGTON, July 21 - The Food and Drug Administration on Thursday announced the recall of 206,000 pumps that deliver medicines intravenously to patients. The announcement was made after three people died and six became seriously ill when the infusion pumps unexpectedly shut down.

The machines, made by Baxter International and known as Colleague volumetric infusion pumps, 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.

"We've received hundreds of complaints from hospitals about these pumps," said Timothy Ulatowski, director of the office of compliance in the F.D.A.'s device center. "That's extraordinary."

Because some hospitals depend entirely on the pumps, the agency is not ordering that they all be sidelined. 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, Mr. Ulatowski said. If the machines shut down in particular ways, they must be taken out of service, he said.

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."...


http://www.nytimes.com/2005/07/22/national/22fda.html