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Old Kidney Machines Caused Deaths

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WebMD Health News

April 25, 2000 -- It started with bloodshot eyes and headache. It ended with blindness, deafness, and death. The bizarre and tragic 1996 event had never happened before and -- according to a government report published in the April 26 issue of the Journal of the American Medical Association -- likely never will happen again.

The seven patients hooked up to artificial kidney machines in a Huntsville, Ala., hospital didn't know anything was wrong when their machines began beeping. The alarms warned that the membranes filtering impurities out of their blood might be leaking. It's not unusual for these sensitive devices to sound a false alarm, and that's what the attendants thought -- until six of the machines had signaled a problem. All seven patients had their filters changed, including one who had been hooked up for only five minutes. But all came down with symptoms.

Within 48 hours, the five women and two men developed terrible headaches, dizziness, and loss of hearing and sight. Although three of the patients got much better within a month, five of them died over the next 13 months. Two died within five days of the event.

What went wrong? The more than 11-year-old filters used in the kidney machines had an unusual chemical breakdown, according to an extensive investigation by the FDA and the CDC. This breakdown could only have happened in very old filters (known as dialyzers) that were improperly manufactured, says lead investigator Joseph C. Hutter, PhD. Hutter is an FDA chemical engineer.

Apparently, many factors must come into play for something like this to happen. "You have to have a manufacturing upset when you are making these things -- plus a long time in storage," Hutter tells WebMD. "We can reproduce that event in the lab. ? With a normal dialyzer, if it was fabricated right, nothing will happen to it. ? You have to have acidic exposure and then exposure to heat. And there is still something else going on because it didn't happen every time [the experiment was performed]. There must have been some impurity or something else we can't identify."

All of the suspect kidney filters were thrown out and burned before CDC investigator Matthew J. Kuehnert, MD, arrived on the scene. However, by finding and then testing many old dialyzers of many different types, the investigators were able to determine that under certain conditions, old filters sometimes gave off toxic chemicals. These toxic chemicals caused eye problems in laboratory animals that were very much like the symptoms seen in the seven patients.

"This was a very unusual event that hasn't been reported before or since," Kuehnert, co-author of the report, tells WebMD. "This is a unique syndrome constellation of very severe symptoms that resulted in permanent disability in many of these patients due to a substance from aged dialyzers. FDA and CDC have issued recommendations to prevent this sort of unusual event from happening again, and that includes rotating dialyzer stock and having dates on them. For the future, it is important to have surveillance in place so if events occur or if there is a cluster of events, that is picked up."

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