Draeger Carina Sub- Acute Care Ventilators Recalled
German medical and safety technology provider Draegerwerk AG & Co. KGaA initiated a recall for Dräger Carina Sub- Acute Care Ventilators, the U.S. Food and Drug Administration said.
According to the agency, the action by the company is to address possible contamination of the breathing gas with 1,3- Dichloropropan-2-ol, a constituent of the PE-PUR foam used for sound insulation. It is considered to be acutely toxic and a potential carcinogen.
The recall incolves Draeger Carina Sub-Acute Care Ventilator with part number 5704110 and UDI number 04048675398516.
The affected Carina ventilators were manufactured from November 1, 2006, through November 30, 2019, and was distributed in the U.S. from March 16, 2009, through October 20, 2012. Outside the U.S., the Carina ventilator was distributed from May 23, 2007, through February 3, 2022.
Certain standard tests conducted by the company in the Carina ventilators measured concentrations of 1,3-Dichloropropan- 2-ol above the acceptable uptake level during continuous use in pediatric patients.
As per Draeger’s investigations, a setting of higher minute volumes leads to lower concentrations in the breathing air.
1,3-Dichloropropan-2-ol is a constituent of the polyurethane foam, which was not discovered in the breathing gas during previous biocompatibility tests conducted within the framework of product approvals and modifications.
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 (eyes, nose, respiratory tract, skin), hypersensitivity, nausea/vomiting, toxic and carcinogenic effects. There have been no reports of death as a result of such exposure.
These issues may result in serious injury, which can be life-threatening, cause permanent impairment, and/or require medical intervention to preclude permanent impairment.
However, the company has not recived any complaints relating to this issue to date.
Draeger had discontinued production of the Carina ventilator in 2019. At present, the company is planning to remove the foam from Carina ventilators still in use and replace with a newly designed blower cover, without additional foam, for noise reduction purposes.
As per the current planning, the newly designed blower cover will be available in the early part of the fourth quarter of 2023. At that time, the local Draeger Service representative will contact Carina customers for the update to be carried out free of charge.
The company expects to update all devices still in use within 8 months of the update being available. Once the Carina ventilator has been updated, it can be used again as normal.
Carina ventilator customers may continue using the devices until they have been modified, subject to certain conditions, such as the set minute volume exceeds 3.6 l/min, only adult patients are ventilated, only a ventilation hose with Dräger leak valve is used; and an inline bacterial filter is used in accordance with the Instructions for Use.
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