Baxter settles suit over med-delivery pumps
Baxter International has settled allegations by the
U.S. Justice Department that two of its medication-delivery pumps were
flawed and violated federal law.
In Chicago, U.S. District Judge Wayne Anderson approved a consent decree in which Baxter agreed to stop making and
distributing the pumps until it complies with federal regulations
and addresses problems that seem to have caused some of the devices to malfunction.
The suit was filed in late 2005 after Food and Drug Administration regulators raided two of Baxter’s warehouses, seizing more than 7,000
pumps on the grounds that they were defective. The seizure was prompted by reports of the deaths of eight patients, and serious illnesses and injuries suffered by 16 others as a result of the
sudden shutdown of their Baxter pumps.
The government’s lawsuit alleged that Baxter’s methods, facilities and controls in the manufacture, packing, storage and
installation of the devices “failed to conform with current good manufacturing practice.” One of the common problems cited by the FDA was the location of the pumps’ “on/off”
button, which is adjacent to the “start”
button. This has led to frequent, inadvertent shutdown of the
machines by nurses and other health care professionals; the location
and placement of the switches caused people to turn the pumps off when they
actually intend to start them.