Harry Kraemer's Moment of Truth

The studies that were done after the deaths in Spain had exonerated the dialyzers. But now, says Heller, "I knew that there was too much there to be a coincidence." The filters in Croatia were probably manufactured around the same time as the ones in Spain. What's more, the recent deaths had occurred at six locations, and the patients weren't all elderly. The clustering in two different countries was highly unusual. Something was wrong with the filters.

Suddenly, Baxter's world exploded. The deaths were front-page news every day in the Croatian newspapers. The Croatian health ministry, like regional officials in Valencia, refused to release the used filters to Baxter for testing. The possibility of tampering was broached.

For Heller, the first decision was obvious. He ordered a global recall of all of Althin's filters and a distribution hold on the ones that had already been made. The action, Heller says, cost Baxter about $10 million. "But the cost was minimal compared to the potential cost to patients if we went ahead with the product," Heller says. Clearly, too, Baxter's legal liability would have been enormous if it had failed to act and more patients died.

Heller assigned Marla Persky to head an internal task force charged with confronting the debacle. Persky, a deputy general counsel who was responsible for the renal division's legal and government affairs, had overseen the integration of the Althin acquisition. Persky pulled in staffers worldwide from quality, manufacturing, toxicology, marketing, communications, clinical affairs, and other departments. That evening, the team of 27 gathered for their first conference call. They would talk twice a day for the next month, working to identify the gaps in their information and where they needed expertise. They hired forensic toxicologists to reexamine the returned filters. They combed through documents, hoping to find anything - a change in the manufacturing process, a new supplier, perhaps different packaging.

And they found nothing. Neither did a team of European physicians assembled by Baxter. Finally, a quality engineer in Althin's Ronneby, Sweden plant noticed something unusual about one of the recalled filters. At one end of the device, between the fibers and a potting compound, were a few bubbles. The bubbles weren't supposed to be there.

A dialysis filter is a disposable product that costs less than $15. The technology is pretty straightforward.At Althin, each filter was tested several times before shipping. An air test determined whether there were any leaks. For the 10% of filters that did leak, workers injected a solution to locate the problem for repair. That solution was supposed to be vacuumed and evaporated from the filters. But the bubbles were evidence that trace amounts of the liquid remained. The solution, made by 3M, had been labeled as nontoxic - and chemically, it was. But when heated to body temperature in a patient's bloodstream, the toxicologists theorized, it gasified, causing a fatal pulmonary embolism.

No one at Baxter knew why the solution was removed from some filters and not others. The apparent randomness made little sense. "Why now?" Persky remembers wondering. "Why not a year earlier? Why not for other manufacturers?" Why wasn't the solution tested for reaction to temperature? Because 3M never intended it to come into contact with anyone's bloodstream. Why was it used at Ronneby? Because the contractor who designed the process there had done the same thing for another company. Why hadn't the earlier analyses identified the problem? Because when technicians opened the filters for testing, the trace liquid evaporated.

"There will always be a thousand 'why's," Persky says now. "So we had to focus on the 'what.' " And on November 2, when test results confirmed Baxter's working hypothesis, the what became unavoidable. Rabbits injected with the 3M solution had nearly died, exhibiting the same symptoms as the patients in Spain and Croatia. The following morning, a Saturday, Heller called Kraemer at home to lay out the situation. Kraemer was packing the car for a camping trip with his daughter. Heller reported on the animal tests and their implications. He explained Baxter's options. After a discussion about Baxter's likely strategy, Kraemer told Heller, "Let's make sure we do the right thing." Then he went camping.

"What Harry Says He Believes In"
What is it, exactly, that makes Kraemer so different from your typical big-company CEO? He has a rumpled, boyish look to him, resembling the actor Michael Keaton in dowdy pinstripes and a button-down shirt. He is an accountant by training, with an MBA from Northwestern's Kellogg School of Management. He is a Midwestern native and a devout Catholic. He drives a Toyota Avalon.