Draegerwerk AG & Co. KGaA initiated a voluntary recall notification for Draeger Carina Sub-Acute Care Ventilators 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. To date, Draeger’s market surveillance activities show that no complaints relating to this problem have been reported.

To determine the long-term stability of the polyether polyurethane (PE-PUR) foam used for sound insulation in Carina ventilators, Draeger subjected devices of different ages to biocompatibility tests. For Carina ventilators operated for periods of up to 15 years, no age-related degradation or decay products associated with degradation were found in those standard tests.

However, certain standard tests conducted by Draeger measured concentrations of 1,3-Dichloropropan-2-ol above the acceptable uptake level during continuous use (>30 days) in pediatric patients. Draeger’s investigations determined that a setting of higher minute volumes leads 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 on adult patients.

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.

In literature, 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. To date, Draeger has not received any reported symptoms of an acute toxic reaction, nor any other complaints relating to this issue via our market surveillance.

Although Draeger discontinued production of the Carina ventilator in 2019, 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.

Carina ventilator customers may continue using the devices until they have been modified, provided the following conditions are met:

  • The set minute volume exceeds 3.6 l/min
  • Only adult patients are ventilated
  • Only a ventilation hose with Draeger leak valve is used
  • An inline bacterial filter is used in accordance with the Instructions for Use

According to current planning, the newly designed blower cover will be available in the early part of the fourth quarter of 2023. Once available, the local Draeger Service representative will contact Carina customers to schedule a time for the update to be carried out free of charge. Draeger estimates that all devices still in use will be updated within 8 months of the update being available.

Once the Carina ventilator has been updated, it can be used again as normal. The modification will not change the overall function of the Carina ventilator.

Photo via Draeger