In the most recent patient safety newsletter, CHPSO wrote about
the new FDA initiative on infusion pump safety. Now, The FDA has
asked Baxter to recall and destroy all of its Colleague pumps.
The Colleague line of pumps have been the subject of several
recalls, but the FDA is not satisfied with Baxter’s plans to
bring the pumps into compliance. Baxter is estimating that this
will cost the company about $0.5B.As of today, used pumps are
still for sale by some third-party distributors (and on eBay!)
Here is the FDA’s statement:
FDA NEWS RELEASE
For Immediate Release: May 3, 2010
Media Inquiries: Dick Thompson, 240-753-3049,
Consumer Inquiries: 888-INFO-FDA
FDA Issues Statement on Baxter’s Recall of Colleague
The U.S. Food and Drug Administration sent a letter to Baxter
Healthcare Corp. on April 30 ordering the company to recall and
destroy all of its Colleague Volumetric Infusion Pumps (Colleague
pumps) currently in use in the United States. This action is
based on a longstanding failure to correct many serious problems
with the pumps. The FDA believes there may be as many as 200,000
of those pumps currently in use.
Additionally, the FDA is ordering the company to provide refunds
to customers or replace pumps at no cost to customers help defray
the cost of replacement.
Infusion pumps are devices that deliver fluids, including
nutrients and medications, into a patient’s body in a controlled
manner. They are widely used in hospitals, other clinical
settings and, increasingly, in the home because they allow a
greater level of accuracy in fluid delivery.
Hospitals and other users of Baxter’s Colleague pumps will be
receiving further instruction and information from Baxter and the
FDA regarding their transition.
The FDA has been working with Baxter since 1999 to correct
numerous device flaws. Since then, Colleague pumps have been the
subject of several Class I recalls for battery swelling,
inadvertent power off, service data errors, and other issues.
In June 2006, the FDA was obtained a consent decree of permanent
injunction in which Baxter agreed to stop manufacturing and
distributing all models of the Colleague pump until the company
corrected manufacturing deficiencies and until devices in use
were brought into compliance. Since then, Baxter has made
numerous changes to the Colleague pumps but these changes have
not corrected the product defect leading to the permanent
On April 8, 2010, Baxter submitted a proposed correction schedule
to the FDA that stated that Baxter did not plan to begin the
latest round of corrections to the adulterated and misbranded
pumps until May 2012. The proposal also stated that Baxter does
not anticipate completion of the proposed corrections until 2013.
On that schedule, a device with known safety concerns would
remain in use on patients needing specialized care until 2013.
FDA found this proposal unacceptable. The 2006 consent decree
gave FDA authority to take any action it deemed appropriate. The
FDA has determined that this action is necessary, as Baxter has
failed to adequately correct, within a reasonable time frame, the
deficiencies in the Colleague infusion pumps still in use.
Therefore the FDA is now ordering Baxter to:
Recall and destroy all Colleague infusion pumps.
Reimburse customers for the value of the recalled device
Assist in finding a replacement for these customers.
Infusion pumps, including the Baxter Colleague models, have been
the source of persistent safety problems. In the past five years,
the FDA has received more than 56,000 reports of adverse events
associated with the use of infusion pumps. Those events have
included serious injuries and more than 500 deaths. Between 2005
and 2009, 87 infusion pump recalls were conducted to address
identified safety concerns, according to FDA data.
An FDA analysis of these adverse events has uncovered software
defects, user interface problems and mechanical and electrical
failures. Problems with infusion pumps are not confined to one
manufacturer or one type of device.
In response, last month the FDA announced a new initiative to
address safety problems associated with infusion pumps. As part
of its initiative, the FDA is moving to establish additional
premarket requirements manufacturers will be expected to meet, in
part through static testing in FDA’s facilities before device
submissions. The FDA is also holding a May public workshop on
infusion pump design, and the agency is raising public awareness
of the issue among health care workers and patients.