On June 29, Baxter International Inc. and two of its top executives settled U.S. Justice Department allegations that two of its medication delivery pumps, the Colleague Volumetric Infusion Pump and the Syndeo PCA Syringe Pump, were flawed and violated federal law. (Read Consumer Alert: F.D.A. Orders Class 1 Recall of Baxter International's Colleague Volumetric Infusion Pumps.)
In a consent decree approved by U.S. District Judge Wayne Anderson in Chicago, Deerfield-based Baxter said it would stop manufacturing and distributing the pumps and until the company complies with federal regulations and fixes problems that appear to have caused some of the devices to stop operating.
The suit was filed last fall after federal regulators seized more than 7,000 pumps from two of Baxter’s warehouses, claiming they were defective. The F.D.A.'s seizure was prompted by reports of the deaths of eight patients and the serious illnesses and injuries suffered by 16 other patients as a result of the unexpected shut down of their Baxter Colleague pumps.
In its lawsuit the government alleged that "the methods used in, and the facilities and controls used for, their manufacture, packing, storage and installation did not conform with current good manufacturing practice" and the government's quality system regulation for devices. One of the common problems with these pumps that were cited by the F.D.A. was the location of the “On/Off” button. The pump design placed the “On/Off” button right next to the “Start” button. This switch placement has led to the inadvertent shut down of these machines by nurses and other health care professionals who had actually intended that the pumps either begin or continue drug therapy. This switch placement design defect is potentially fatal for a very simple reason - - the location and placement of the switches causes people to turn the pumps “Off” when they actually intend to turn them “On.”
Under the agreement Baxter must post a $20 million bond with the court to assure its compliance, the U.S. attorney's office said. If Baxter fails to comply, the company could face penalties up to $10 million a year. Baxter signed the consent decree without admitting to the allegations or claiming liability, the government said.
If you or someone you know is using a Baxter Colleague pump you should discuss these product defect problems with the treating health care provider. If you or someone you know would like further information concerning a malfunctioning Baxter International Colleague Volumetric Infusion Pump, and you wish to consult with us, please call Gary Wilson at 612-349-8413. You can also send him an e-mail by clicking on this link: contact us.
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