(More recent news story postings on this topic can be accessed by clicking here.)

November 4, 2001 - The Spanish Health Ministry released a preliminary report on Sunday that it said established a connection between the deaths of 11 dialysis patients and Baxter's recently recalled dialyzers. A full report is expected later this week.

November 3, 2001 - There are now 51 dialysis patient deaths being investigated as possibly related to the use of recalled Baxter dialyzers.

Locations of patient deaths: 23 in Croatia, 15 in Spain, seven in Taiwan, two in Columbia, two in Texas, and two in Nebraska.

October 30, 2001 - Officials from the Food and Drug Adminstration are in Ronneby, Sweden inspecting Baxter's manufacturing plant and records as part of their investigation into 44 dialysis patient deaths that may be related to the use of dialyzers. This article is from Crain's Chicago Business Newsroom and requires registration (free) to view.

October 29, 2001 - The Food and Drug Administration has increased by eleven the number of deaths being investigated that may be related to the use of recently recalled Baxter dialyzers. Here is a summary of an article that appeared today in Crain's.

The full text of the Crain's article is available on-line, but requires registration (it is free).

These eleven newly reported patient deaths occurred in Taiwan, Columbia, and the state of Nebraska. This brings the total number of patient deaths under investigation to 44.

October 27, 2001 - This week's issue of the British Medical Journal (BMJ) has an update on investigations in Croatia and Spain relating to the recalled Baxter (Althane) dialyzers.

October 24, 2001 - This article from the Chicago Tribune/FT includes comments from a telephone interview with the Croatian Health Minister who resigned yesterday.

According to the article, Dr. Ana Stavljenic-Rukavina, who describes herself as a physician and biochemist, said "pathology reports on 14 patients indicates that the patients died when membranes on the filters produced air bubbles that led to heart or lung failure."

Baxter complains that it "is being shut out of the Croatian government's investigation."

Baxter has posted a new letter on its web site to customers.

October 23, 2001 - Baxter has posted a news release on its web site entitled, "Baxter Responds to Dialyzer Test Results Reported by Croatian Health Authories". The news release states:

"Baxter has read in some newspaper reports that a chemical called cresolphenolbenzidine could potentially be associated with these cases, although the Croatian Ministry of Health has not reported that it has found any such chemical. Baxter can confirm that this substance is not part of the company's manufacturing processes in its Ronneby or Miami Lakes facilities."

Bloomberg Financial News reports that Baxter says it is too early to comment on an investigation which found the deaths of 23 kidney-failure patients in Croatia were probably caused by the A-series dialyzers.

Croatian Prime Minister Ivica Racan relieved Health Minister Ana Stavljenic Rukavina of duty at a government session today. Here is the report from the BBC/Financial Times.

An article in Transitions Online yesterday stated that "all autopsies of the 21 kidney patients who died during or after dialysis in Croatian hospitals contained information on blood foaming up".

Transitions Online (web site) is Internet magazine covering Central and Eastern Europe, the Balkans, and the former Soviet Union.

October 22, 2001 - It is now being reported that the deaths of two U.S. dialysis patients, under investigation as possibly linked to the use of recalled Baxter dialyzers, occurred in Austin, Texas last Tuesday (October 16).

On Saturday, October 20, The Austin American-Statesman reported information about the incidents that occurred at a Capital Dialysis of Texas facility in Austin (link no longer valid).

Here is the October 20 article from The Guardian (UK) about the dialysis patient deaths in Croatia, Spain and the U.S.

October 20, 2001 - Baxter has set up an information page on its web site regarding the recall of the Series A, AF, and AX dialyzers.

They have added a letter to patients (Oct. 19).

October 19, 2001 - (11:07 AM EDT) Croatian officials said today they had found evidence indicating that dialyzers were to blame for the deaths of 21 kidney patients. Story from Reuters/Yahoo.

Croatian Deputy Health Minister Rajko Ostojic said laboratory analysis of the dialyzers used to treat the patients who died had shown up a substance not normally present. This substance has not yet been identified.

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Here is the product recall letter from Baxter dated October 18. (WORD document)

According to the letter, the recall includes:

• A15, A18 and A22 Dialyzers (237015, 237018, 237022).
  
  
• AF150, AF180, AF220 (238015, 238018, 238022) Dialyzers.
  
  
• All lots of the above product codes.

Here is the latest report from the Chicago Tribune (Oct. 19) on the dialysis patient deaths in Texas.

According to the article, Baxter has expanded the recall to include its Series AX dialyzers, which are sold only in Europe and are no longer marketed. The Series A and Series AF dialyzers were recalled earlier on Thursday.

The Baxter stock price fell nearly 10 percent during yesterday's trading but recovered to close down 3.7 percent.

October 18, 2001 - (8:02 PM EDT) - The Food and Drug Administration (FDA) has begun investigating the cause of the two dialysis patient deaths in Texas that involved the use of recently recalled Baxter dialyzers.

(6:53 PM EDT) - Details are still sketchy on the two dialysis patients in Texas that were using the just-recalled Baxter dialyzers and then died suddenly.

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Here is the latest report from the Financial Times concerning the Baxter dialyzer situation in the US.

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(2 pm EDT) It is now being reported that two dialysis patients in Texas have died suddenly while using the same Baxter dialyzers that were recalled, the A and AF series

(The reference to the Texas location was removed from the 3:20 pm update to the previous story, but is included in this early version.)

The patients were about half-way through their dialysis treatments when the deaths occurred, a spokeswoman said. The cause of death was not yet known and no additional information was immediately available. Two more patients were hospitalized, and one of them has been released, she said.

Baxter called the recall a precaution, adding it was not clear whether the dialyzers caused the deaths.

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Baxter International has started a global recall of its Series A and Series AF dialyzers. A possible link between these dialyzers and the deaths of 30 European dialysis patients is under investigation at this time. This October 18th article is from the Chicago Tribune.

Baxter spokeswoman Deborah Spak is quoted, "Until more information is available to determine the cause of the deaths that occurred in Croatia, we think it is prudent to recall these dialyzers."

An opposition political party in Croatia is now calling for the resignation of the Health Minister, Ana Stavljenic Rukavina

Here is the most recent article from the Financial Times (FT) (UK).

According to the FT article, the US Food and Drug Administration (FDA) is investigating whether the dialyzers, sold in more than 20 countries, had been used in US clinics. The FDA said it had been in contact with Baxter to determine where the dialyzers had been sold.

Even the prime minister of Croatia, Ivica Racan, has commented on the situation.

October 17, 2001 - Two sources are reporting that Baxter has initiated a worldwide recall of some of its dialyzers. While the articles mention no specific dialyzer models, it is assumed it would be the A-15 and A-18 models that were involved in the patient deaths in Croatia.

Here are the stories from the Associated Press (5:21pm) and from Reuters Securities (4:02pm).

The Croatian medical supply firm Pliva has suspended commercial relations with Baxter. Pliva distributed Baxter dialyzers in Croatia.

Also, according to this story, the Croatian Deputy Health Minister Ranko Ostojic said 21 deaths in eight Croatian dialysis centres "were most probably caused by air bubbles created at the membrane of the filter that cleans the blood of patients with malfunctioning kidneys. The bubbles entered the patients' bodies and caused irreparable heart or lung failure."

Baxter has not seen any collaborating evidence to support the ministry's claims. Baxter spokeswoman Patty O'Hayer said, "Until such a time as we have access to that information, we don't believe we have any position to make a statement to refute or support allegations from the ministry or anyone else."

Here is another report from AFX/European Investor as of 4 pm on October 16.

This report states that 21 of the patients who died were using Baxter dialyzers. Baxter has now decided to stop the worldwide distribution of its A-series dialyzers as a precautionary measure. A-15 and A-18 dialyzers were used in Croatia.

October 16, 2001 - As a precautionary measure, Baxter International has stopped distributing the Pliva-distributed P series of dialyzers (also known as the Baxter A series) and is advising its customers to stop using any of these dialyzers that they have in stock. Here is the latest news story from CNN.

It is now reported that 22 of the 23 patients who died used the Pliva-distributed P series dialyzer.

October 15, 2001 - On Friday night, October 12, a hospital in Pozega in central Croatia reported the deaths of four dialysis patients. Communications with other Croatian hospitals late Friday and through Saturday revealed that 23 patients had died in several clinics, beginning on Monday. Normally 3-6 dialysis patients die per week in Croatia.

Thus far, the only commonalities in the deaths appear to be the use of Baxter dialyzers and solutions from a local company, however no evidence points to the either the dialyzers or the solutions as the cause of the deaths. According to the Croatian media, some of the 23 victims died during dialysis treatment, while others died from choking or heart problems shortly afterwards.

Croatian Health Minister Ana Stavljenic Rukavina has offered to resign over the deaths, most of which happened on Friday and Saturday.

Here are several sources that are reporting on this story:

Wall Street Journal.com - Monday, 15 October, 2001

Reuters - Monday, 15 October, 2001, 01:58 EST

BBC News - Monday, 15 October, 2001, 06:54 GMT

Statement from PLIVA, the company that distributes Baxter dialyzers in Croatia and provides solutions used for dialysis - October 15

The Guardian - United Kingdom; Oct 15, 2001

Associated Press/Yahoo - Sunday October 14 3:14 PM ET

Reuters/Yahoo - Sunday October 14, 2:50 pm Eastern Time

Baxter is establishing an independent expert panel of Nephrologists to ensure patient safety and will cooperate fully with authorities in a comprehensive investigation. Here is a press release from Baxter.

Here is a news summary from RenalWEB on the controversy surrounding the recent dialysis deaths in Spain.




[This message has been edited by Gary Peterson (edited 11-08-2001).]