HQ Team
August 5, 2023: Drägerwerk AG & Co., a German maker of medical safety equipment, has initiated a worldwide voluntary recall of its ventilators to address a possible contamination issue.
Dräger Carina sub-acute care ventilators were subjected to biocompatibility tests to determine the long-term stability of the polyether polyurethane foam used for sound insulation, according to an FDA statement.
Certain standard tests conducted by Dräger measured concentrations of 1,3-Dichloropropan- 2-ol, a constituent of the foam, and found it to be above the acceptable uptake level during continuous use.
The contamination was found in pediatric patients who used the ventilator for 30 days or more.
15-year working period
“To date, Dräger’s market surveillance activities show that no complaints relating to this problem have been reported.
Carina ventilators can operate for periods of up to 15 years, and no age-related degradation of the products was found in those standard tests, the FDA stated.
Dräger’s investigations found that a setting of higher minute volumes led to lower concentrations in the breathing air.
“At a minute volume greater than 3.6 l/min, the measured concentrations were in the acceptable range for continuous use in adult patients.”
Potential carcinogen
Tests conducted earlier did not show the contamination in the breathing gas.
The constituent 1,3-Dichloropropan-2-ol is considered to be acutely toxic and a potential carcinogen.
Potential risks of chemical exposure due to off-gassing include, headache, dizziness, irritation in eyes, nose, respiratory tract, and skin, hypersensitivity, nausea, vomiting, toxic and carcinogenic effects.
These issues may result in serious injury, which can be life-threatening, cause permanent impairment, or require medical intervention to preclude permanent impairment.
There have been no reports of death as a result of such exposure, according to the FDA.
Production discontinued
Dräger discontinued production of the Carina ventilator in 2019, and the company is planning to remove the foam from Carina ventilators still in use and replace it with a newly designed blower cover, without additional foam, for noise reduction purposes.
Worldwide, the Carina ventilator was distributed to customers by Dräger Sales and Service entities. The Carina ventilator was manufactured from November 1, 2006, through November 30, 2019.
In the US, the Carina ventilator was distributed from March 16, 2009, through October 20, 2012.
Outside the US, the Carina ventilator was distributed from May 23, 2007, through February 3, 2022.
Carina ventilator customers need to the set minute volume exceeds 3.6 l/min, and ensure only adult patients are ventilated.
The company advised customers to use an inline bacterial filter.
New blower cover by Q4
A newly designed blower cover will be available in the early part of the fourth quarter of 2023.
Dräger estimated that all devices still in use would be updated within eight months of the update being available. “The modification will not change the overall function of the Carina ventilator.”
Founded in 1889, Dräger generated revenues of around three billion euros in 2022. The Dräger Group is currently present in more than 190 countries.
