FDA-Approved Device Was Contaminated

A probe used to measure the carbon dioxide level in patients has been recalled after the device was found to have caused infections in critically ill children. Three of the children died in the ICU at Children's Medical Center in Dallas. The infections were due to a bacterium called Burkholderia cepacia, according to the succinct and somewhat sanitized news release (below) from the FDA.

Comment: Burkholderia cepacia (or B. cepacia, for short) is the name for a group of bacteria that can be found in soil and water. B. cepacia bacteria are often resistant to common antibiotics. They pose little medical risk to healthy people. However, people who have certain health problems like a weakened immune systems or chronic lung disease, particularly cystic fibrosis (CF), are more susceptible to infections with it. Transmission of these bacteria has been previously reported from contaminated solutions and medical devices as well as contaminated over-the-counter nasal spray and contaminated mouthwash. Decisions on the treatment of infections with B. cepacia are best made on a case-by-case basis. Usually it can be treated with drugs called Trimethoprim-sulfamethoxazole or Meropenem.

Barbara K. Hecht, Ph.D.
Frederick Hecht, M.D.
Medical Editors, MedicineNet.com


FDA Announces Nationwide Recall of Nellcor Puritan Bennet Probes Device

FDA announced that Nellcor Puritan Bennett (Tyco Healthcare/Mallinckrodt) is conducting a nationwide recall of all of its CapnoProbes, a device similar to an electronic thermometer that is used by hospitals to measure the carbon dioxide in patients' tissues. Each probe is packaged in a metal canister filled with a saline solution and sealed in a foil envelope labeled as non-sterile. All of the CapnoProbes were manufactured at Nellcor's facility in Tijuana. Mexico. The probe and associated saline contain the bacteria Burkholderia Cepacia and other opportunistic pathogens that can cause serious infections, usually in persons who have decreased resistance to infection.

FDA first learned of a potential problem with the product when notified by the Texas Department of Health on August 18. Positive cultures were found in at least 11 patients in the pediatric intensive care units of Childrens Medical Center in Dallas. An association with these specific culture findings and patient outcomes has not been established at this time. On August 19, FDA sent an investigator to Nellcor Corporate headquarters in Pleasanton, Calif., to conduct an inspection, which is ongoing.

On August 24, Nellcor notified its customers that they were recalling all lots of the CapnoProbe SLS-1 Sublingual Sensors and asked hospitals to return any unused inventory. The firm said the probe may pose a hazard to patients with compromised immune systems. Both FDA and Nellcor Puritan Bennet are continuing their investigations.

Healthcare facilities that are aware of deaths or injuries related to use of the CapnoProbe should report them to Nellcor and to the FDA through the MedWatch program at /www.fda.gov/medwatch/index.html

Physicians and patients can obtain further details about the recall from Nellcor at 1-800-635-5267, option 3.

Source: FDA news release #P04-82, August 27, 2004


Last Editorial Review: 8/30/2004