FRIDAY, Aug. 27, 2004 (HealthDayNews) -- A probe used by hospitals to measure gas in patients' tissues has been recalled after the device was linked to several infections in critically ill children, three of whom died.
The recall, announced by the U.S. Food and Drug Administration Thursday, was undertaken voluntary by Nellcor Puritan Bennett Inc., the company that makes the CapnoProbe, after a cluster of infections with the bacterium Burkholderia cepacia came to light in intensive care units (ICU) at Children's Medical Center in Dallas.
According to hospital officials, 13 children were infected out of a total of 115 children who had been exposed to one of the probes since December 2003. Eight of the 13 were still in their first month of life, and were in the ICU for other reasons.
Three of the 13 children died, but it was not immediately clear whether the infections were the cause.
The FDA said in a statement that the infections were "life-threatening." But Dr. Jane Siegel, chairwoman of the infection control committee at Children's Medical Center, said Friday that most were not.
Two of the infants died apparently because of their underlying disease, she said. "It does not appear that infection played a role as best as we can tell," Siegel said.
In the case of the third infant, who was 16 days old, "it is possible that infection is a contributing factor," but not the sole cause, said Siegel, who is former co-chair of the infection control practices committee at the U.S. Centers for Disease Control and Prevention.
B. cepacia is associated with the use of contaminated equipment and solutions and is known to strike people with weakened immune systems.
The CapnoProbe, which measures the amount of carbon dioxide in tissue, won FDA approval in 2002, according to Randy Krotz, a spokesman for Tyco Healthcare, Nellcor's parent firm.
According to the company, about 5,600 probes have been shipped since January 2003, and the device is used nationwide in about 60 health-care centers.
There wasn't a lot of information on how well the device worked in small children, however. That's why Children's Hospital had undertaken a study "to see if this product would help us in caring for children," Siegel said.
It was not a safety study, she added, because safety was never in question.
According to the FDA, eight of the children who got infections were part of that study.
The device is noninvasive and works much the same way as a thermometer, by being placed under the tongue.
The problem first came to light on April 30 when the hospital lab turned up a case of B. cepacia.
"That particular organism is, for us, a target organism that we track carefully because we know it shouldn't be there," Siegel said. "It can be sign of contaminated fluids."
The hospital started looking for contaminated water sources on equipment in the ICU. At the time, they were unaware of the use of the probe, Siegel said.
The hospital then went for long stretches (one month and six weeks) with no reports of infections with this bacteria at all.
Then three children all developed the infection within 12 hours of being admitted to the ICU, Siegel said.
"We started to focus [on] procedures in the early hours of admission, and that is when it came to our attention that this probe was being used," Siegel said. "When we heard it was packaged in saline solution, we became very suspicious."
Each probe is packaged in a metal canister filled with saline solution and sealed in a foil envelope labeled as non-sterile.
The hospital had five probes that were unopened. Of those five, four grew B. cepacia, while the fifth grew another bacterium. Hospital officials immediately contacted health authorities.
The company had changed its manufacturing facility to one in Tijuana, Mexico, but that change occurred in January 2003 and no infections were seen until almost a year and a half later.
"We haven't at this point been able to draw a clear correlation with the manufacturing facilities, and obviously that's something we're paying very close attention to," Krotz said.
Nellcor contacted its customers on Aug. 24, telling them to discontinue use of the device and to return any inventory to the company.
Investigations by the hospital, the company, and federal health authorities are still under way.
For more on B. cepacia, visit the American Phytopathologial Society.