Filtering Through The Baxter Dialysis System

August 2001 - It's Only Just Begun….
Although studies conducted by Baxter have not indicated a malfunction of any kind, nor produced evidence connecting Baxter's products to the deaths of the 11 patients undergoing kidney dialysis, for precautionary measures, Baxter recalls two batches of A-18 dialyzers.

October 2001 - Baxter's Althane A-18 Dialyzers confirmed safe.
Confirmation of the safety of this product not only comes from Baxter's researchers, but an independent medical device investigator TUV Product Service in Europe concurred. Nevertheless, 460 fibrous dialysis filters were pulled from two different hospitals in Spain where a total of 10 people have died while receiving kidney dialysis treatment.

Upon further study by the European TUV Services, an irrefutable conclusion was reached that Baxter's A-18 model dialysis filter was safe.

Japan starts massive recall, just to be safe.
There have been no reports of any injury or death for patients that had been using the T series medical equipment for artificial dialysis, and Japan plans to keep it that way. 80% of the products have been pulled. JMS Co. has decided to play it rather safe than sorry. JMS Co., a Hiroshima-based producer of medical products, uses the very same parts that Baxter is recalling. 210 medical institutions and Japanese wholesalers feel the affect.

November 2001 - Following the trail of death. It's gone worldwide.
At an Austin, TX dialysis clinic, 2 patients have died cleansing their blood with the system equipped with a Baxter filter. Although Baxter stopped distribution of the filter worldwide last month, the recall wasn't initiated until Nadar recommended it.

51 people dead at this point. All were using the dialysis system equipped with the Baxter filter.

Baxter holds firm to their statement that there is no evidence linking these deaths to the dialyzers.

All six of the recalled dialyzers, series A and AF, were produced in Baxter's plant in Ronneby, Sweden.

Folks, the connection we have all been waiting for…
The Minnesota Mining & Manufacturing Company, more commonly known as 3M, supplies Baxter with a chemical intended for cleaning electronic products and devices. NOT HEALTHCARE! Baxter was using the product on the filters to determine any signs of leakage and absorption of blood. If a filter did exhibit signs of leakage, it would be removed from the production line and subjected to a series of corrective measures, eventually being retested. It was assumed that the product 5070 would evaporate on its own from the filters.

Instead the chemical was introduced into the bloodstreams of dialysis patients throughout four countries.

Spain is the first to take action and bring suit against Baxter for damage done to the Spanish Health service and withholding any information pertaining to the deaths.

Baxter coyly admits that its filter may have played a role in the deaths of the (now) 53 patients who were using the filter equipped device, acknowledging the company's plan to assume an after- tax charge of $100 - $150 million to address the problem. Potential liability is estimated at totaling 200 patients, although Baxter admits the numbers may change as the issues are brought closer to the surface.

Analysts are estimating potential liability of 650 patients as a worse case scenario.

The end of it all…….
Over the next three months Baxter felt the impact of their negligence. The Swedish plant was under criminal investigation, possibly leading to charges of involuntary manslaughter, along with labor violations and quality standards... The plant shuts down.

Spain asks for and receives $280 million for the families of the 11 who died.

Baxter chooses to leave 3M out of it. Although Baxter claims it was the chemical produced by 3M that was used for testing the filters that was directly responsible for the deaths, Baxter doesn't pursue legal action. "Nor should they" 3M has said. "The product is sold as a cleaner of industrial electronic parts, not as any part of any healthcare or medical device."

Swedish investigator discontinues his pursuit of Baxter, after he says it became apparent to him that the chain of events leading to what is now believed to be 90 deaths, was nothing more than an "unfortunate mishap".

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