Shortly thereafter, two patients who had undergone open-heart surgery had a devastating infection and died. Nine other heart patients ended up in the intensive-care unit for extended stays.
“It’s normal for people to have an inflammatory response following open-heart surgery, but to have a severe response that results in multi-organ failure — that’s rare,” said John Armitage, who ran the cardiac unit and now lives in Oregon. “We started changing everything we could think of. Nothing seemed to work.”
In September 2005, cardiovascular specialists staged a mock surgery and found the cardioplegia was contaminated with bacteria, according to a hospital analysis.
They repeated the mock surgery to make sure no other factors were contributing to the crisis. This time, the full cardiac team joined in, scrubbing their hands, slipping on sterile gowns, masks and gloves as they walked through each step of an operation while the hospital’s infection-control staff watched. The only thing missing was a patient.
The cardioplegia seemed to be the only problem, the state health department concluded.
When the FDA was notified, Armitage said, it took days for investigators to arrive, and they wouldn’t tell the hospital what they were finding out about the CAPS Lanham facility.
“They said, ‘We are not a police agency,’ ” Armitage said. The hospital filed a Freedom of Information Act request and received the FDA inspection report about six months later.
The FDA found 17 safety violations at the Lanham facility. Cardioplegia was tainted with the species of bacteria that matched those found at Mary Washington. Internal tests showed “the presence of bacteria in a water container used for cleaning. . . . Likewise, sterility testing demonstrated similar bacteria in its drug products.” The Maryland Board of Pharmacy suspended the Lanham facility’s license for two months.
The FDA also found dozens of problems at CAPS’s facilities in Alabama, Pennsylvania and Missouri.
Steen, who left CAPS last year to start his own medical consulting firm, said the cause of the illnesses remains a “mystery.” He noted that the facility sent the drug to a number of other hospitals that didn’t have any problems.
That might have been because Mary Washington had ordered a special formula, said Diane Woolard, director of the Division of Surveillance and Investigation with the Virginia Health Department. “It may have been a contaminated element in those ingredients,” she said.
Officials at CAPS, which has 25 locations and $500 million in annual sales, would not comment on the 2005 event. In an e-mail statement, Mike Koch, a vice president, said, “CAPS is committed to offering the highest quality admixture service to our customers and their patients.”