Company recalls medical device suspected in children's deaths
Friday, August 27th 2004, 2:31 pm
By: News On 6
WASHINGTON (AP) _ A medical supply company is recalling a device used to measure carbon dioxide in patients' tissue after reports that two children who used it died in a Dallas hospital this year, the Food and Drug Administration said Thursday.
The device, which is put under the tongue like an electronic thermometer, is believed to have caused infections in 11 children in intensive care units at Children's Medical Center in Dallas, the FDA said. The agency and the product's maker, Nellcor, a subsidiary of Tyco Healthcare, are still investigating whether the deaths are linked to use of the product.
Since the CapnoProbe Sublingual Sensors were introduced in January 2003, about 5,600 of them have been sold to 60 health care centers nationwide, the company said.
Nellcor learned of the infections in mid-August after being contacted by the Dallas hospital. This week it began contacting health centers that had purchased the product, and manufacturing was halted at Nellcor's facility in Tijuana, Mexico.
The FDA was informed of the possible problem on Aug. 18 and the next day sent an investigator to Nellcor's headquarters in Pleasanton, Calif.
The 11 patients were infected between April and August of this year by a bacteria called Burkholderia cepacia, which has been linked to the use of contaminated equipment and solutions, the FDA said. Eight of the infected children were participating in a Nellcor-sponsored study designed to test the product's safety and effectiveness, the agency said.
The bacteria was either on the sensor or in the saline solution that it is packaged in, said Christy Foreman, a deputy director in the FDA's Office of Compliance.
Nellcor is the only company to manufacture the relatively new product, which is not yet established in routine clinical use, said Tyco spokesman Randy Krotz. By measuring carbon dioxide in tissue, it is intended to provide an early indication of poor circulation.
He said the FDA and Centers for Disease Control and Prevention are investigating possible problems associated with the sensors at two other hospitals, but he could not identify them.
More information is available to doctors and patients by calling Nellcor at 1-800-635-5267.