Archive for Friday, July 28, 2006

Blood tainted with E.coli cited in death of Kansas City-area patient

July 28, 2006

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A hospital patient died after receiving a unit of blood platelets tainted with E.coli bacteria, the Community Blood Center in Kansas City said.

The Food and Drug Administration determined the transfusion, which took place Dec. 21, was a "contributing factor" in the patient's death.

"It truly was a tragic incident, and a very rare series of mistakes," David Graham, director of donor recruitment for the blood center, said Wednesday. "We thought we had a redundant and robust system. We had multiple failures of that system."

Citing patient confidentiality, Graham said he could not discuss the hospital or the patient, other than to say the person was being treated for a serious illness at a Kansas City-area hospital. Only one unit of the tainted substance was released, he said.

E.coli bacteria can cause severe diarrhea and abdominal cramps. Young children and the elderly are at risk for complications that can lead to kidney damage or death. Platelets help with clotting and are used with trauma victims and patients undergoing surgery or cancer treatments.

According to Graham, the center did not want to release information about the December death until the FDA concluded its investigation. "Once they make it public, we take it as it's OK for us to make it public," he said.

The unit - about two- to three-fifths of a pint - was collected from one donor, according to Dr. Jay Menitove, executive director and medical director of blood at the center.

Although the donor never developed symptoms, health officials believe the donor was carrying the bacteria at least briefly, Menitove said. However, officials can't be certain that's what happened.

"He came in perfectly healthy, and when contacted afterward, the donor was still healthy," Menitove said Thursday.

"The definitive answer is we just don't know," Menitove said.

Rich Pendleton, the director of compliance for the Kansas City FDA, said he had no reason to doubt the center's account. Pendleton would not comment further, saying the investigation was ongoing.

The hospital patient became sick from the platelets because they are stored at room temperature, Menitove said.

"In your body it's going to be zapped instantly," Menitove said. "But sitting in bag at room temperature, it gives the small amount of bacteria the opportunity to grow or multiply."

Graham said the center tests all of its blood products for various contaminants but accidentally released the platelets in question.

After discovering the problem, the center notified the hospital within hours of the hospital receiving the tainted unit of platelets, Graham said, but the unit already had been used.

The center immediately notified the FDA, which already was on site conducting a routine inspection, Graham said.

In a warning letter dated March 9, the FDA chastised the blood center, saying its procedures were "not always maintained and followed."

The agency also pointed out problems with inadequate training and said the blood center had failed to maintain adequate records of donors who experienced reactions such as fainting or vomiting.

Graham said the problems had been rectified.

"We made changes to our process, our policy, and we made personnel changes," he said, while declining to say whether anyone had been fired because of the tainted blood transfusion.

Graham said potential donors and the 45,000 people who receive blood and blood products from the Community Blood Center each year had no reason to worry.

"The blood supply is safer now than it has ever been," he said.

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