Oxygen Delivery Device Can Also Deliver Infections
MedSun: Newsletter #6, August 2006

This article appeared in Nursing2006: 36(7):18, July 2006.

By Robert A. Fischer, R.N., M.S.N.

A medical center reported that Ralstonia bacteria had been isolated from tracheal aspirates of seven patients. Six of them were receiving therapy with the Vapotherm 2000i Respiratory Gas Humidification Device, which is used to warm and humidify oxygen and other gases delivered by nasal cannula. Five of the affected patients were infants and one was a toddler. One of these patients died; he had sepsis associated with Ralstonia. Consequently, the manufacturer voluntarily issued an urgent nationwide recall for the Vapotherm 2000i humidification devices.

What went wrong?
Ralstonia organisms are Gramnegative bacteria found in the environment, primarily in water and soil and on plants. Occasionally they’re isolated from respiratory secretions of cystic fibrosis patients. In these cases of Ralstonia colonization or infection, the organism was cultured from the Vapotherm device’s waterside outlet port.
The patient who died had Down syndrome and had undergone surgery to repair cardiac birth defects. The Gram-negative sepsis was thought to have been a factor that contributed to his death. The medical center immediately discontinued use of the device pending further investigation.

Retrospective reviews of patient cultures have identified other cases of Ralstonia colonization associated with Vapotherm humidification devices. As of January, the Food and Drug Administration (FDA) had received reports of positive Ralstonia cultures from 26 hospitals in 16 states.

What actions were taken?
Issued in January 2006, the Class 1 recall of Vapotherm 2000i model is the most serious type of recall, signifying a situation with a high risk of serious injury or death. These devices are used in both acute care and home settings. The manufacturer and FDA advise health care providers to switch any patients using these devices to alternative equipment. Patients who’ve been exposed to the Vapotherm system should be monitored for signs and symptoms of infection, such as fever, poor feeding or irritability, and elevated white blood cell counts. The FDA recommends that clinicians consider Ralstonia infection in the differential diagnosis of symptomatic patients, even if Ralstonia hasn’t been isolated.



Additional Information:

Vapotherm, Inc.
http://www.vtherm.com/recall


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