Device Implicated In Kids' Deaths RecalledAug 26, 2004 | Dallas Morning News
The U.S. Food and Drug Administration on Thursday announced a recall of a medical device implicated in the deaths of two patients and life-threatening infections in 11 others at Children's Medical Center Dallas.
The CapnoProbe, a device that measures carbon dioxide in tissue, was manufactured by Nellcor Puritan Bennett Inc. at a plant in Tijuana, Mexico. It came packaged in a metal canister filled with saline solution labeled nonsterile and worked like a thermometer, according to the FDA.
The agency's statement said the patients were infected with Burkholderia cepacia, a bacterium found among intensive-care patients and associated with contaminated hospital equipment and solution.
Eight of the children were taking part in a study, sponsored by Nellcor, to test the effectiveness of the medical probe in children. The device is placed under the tongue to detect early signs of shock. The cause of the two deaths remained under investigation.
A statement released by the medical center late Thursday said an initial investigation suggested that the device was packaged in contaminated solution.
The FDA said it was notified of a potential problem by the Texas Department of Health on Aug. 18. The next day, the federal agency sent an investigator to Nellcor's headquarters in Pleasanton, Calif., to conduct an inspection.
Nellcor notified its customers Tuesday that it was recalling the CapnoProbe SLS-1 because the device could pose a hazard to patients with compromised immune systems.
The FDA and Nellcor are continuing investigations into what happened in Dallas. Other health-care facilities that may have deaths or injuries possibly related to the product were asked to contact the FDA.