EBME Forums Forums Management Medical Equipment Management Breaking News - Baxter Colleagues!!!

What now for Baxter in the UK?

http://www.whnt.com/business/sns-ap-us-baxter-international-pump-recall,0,3281943.story

you need to copy & paste the above URL

John

Wow! Now that is interesting!

Costly for Baxter but a brilliant outcome for all the poor long suffering users. Will it apply outside the US?

Costly? Catastrophic, surely?

It will be interesting to see which pump they use as a replacement (where users select that option).

As an aside (and to settle a "discussion" here) ... am I right in saying that the basis of the Colleague was the Danby pump (made in the UK)? Did Baxter buy Danby?

The Colleague saga is a great pity, I reckon. The design was certainly advanced - but just brought to market a bit early, I guess.

But (lastly) what is the current state of play with the Colleagues ... anyone care to summarise the outstanding technical problems (if any)?

One can only hope the removal (& refund) will come to the UK market - the design may have been advanced (we all have an opinion on that) but there comes a time when you have to admit - oops, we got it wrong! (anyone remember the Vickers VP44 / 55 pumps?) About time Baxter admitted it.
As for a summary of the outstanding technical problems ... there isn't enough room here!

Update...

(Updates with comments from the FDA)


By Jennifer Corbett Dooren
Of DOW JONES NEWSWIRES
WASHINGTON (Dow Jones)--Baxter International Inc.'s (BAX) healthcare unit said Monday it was recalling all of its Colleague infusion pumps that are widely used in hospitals to deliver medication and other fluids to patients.

The company said the recall was requested by the Food and Drug Administration. Baxter said it will record a pre-tax special charge of $400 million to $600 million in the first quarter for the estimated cost of the recall.

Company spokeswoman Erin Gardiner said in an email that the recall affected about 200,000 pumps.

The FDA said it was ordering Baxter to recall and destroy all of the Colleague pumps because of a "longstanding failure to correct many serious problems with the pumps" which include failures to properly deliver the correct amount of medicine. The agency also noted that infusion pumps are increasingly being used in the home.

The FDA also ordered the company to replace the pumps at no charge to customers or offer refunds. Baxter said it expects to exchange existing Colleague pumps with the firm's Sigma Spectrum pumps.

Baxter has had trouble with the Colleague infusion pump for several years. In 2005, more than 7,000 Colleague pumps were seized at FDA's request after getting reports of 16 patient injuries and seven deaths from pump malfunctions.

In 2006, the company entered into a consent decree with the FDA involving the Colleague and another drug pump known as Syndeo aimed at fixing the problems.

The FDA said although Baxter has made several changes to the Colleague pump, the changes weren't enough to fix the product defects. The agency said the company's most recent proposal to fix the devices didn't 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," the agency said.

Gardiner said the time table was lengthened to meet new FDA infusion pump requirements, which called for more pre-market testing of the products.

Last month the FDA said it was increasing regulation of companies making widely used infusion pumps that deliver drugs and other fluids to patients because of continued problems with the devices, including the Colleague pump.

The FDA said there's been 56,000 reports of problems associated with the use of external infusion pumps and 87 recalls in the past five years. The agency said some of the reports included serious injuries and more than 500 deaths.

-By Jennifer Corbett Dooren, Dow Jones Newswires; 202-862-9294; jennifer.corbett@dowjones.com

(Jon Kamp contributed to this report).

Vickers VP44 / 55 pumps - any pump where the eprom falls out of its holder when the unit is lightly shaken is a winner with me.

A technical summary for the Colleague - they were "bloody useless" and the company tried to ignore the feed back they were getting from the users.

Lee

Definitely Es aitch one tee quality and they " smoked " on the Bench quite well too !!!

Meanwhile ... look out for yet another upgrade (in the UK, at least)!

It is hard to see how a pump can be recalled and replaced in the US and left in place with the rest of the poor unfortunates everywhere else. Is there replacement the Sigma Spectrum CE marked or even launched in europe yet?