Last Updated on January 14, 2024 by The Health Master
Medical Device recall
Dragerwerk AG & Co. KGaA initiated a voluntary recall notification for Dräger 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, Dräger’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, Dräger 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 Dräger measured concentrations of 1,3-Dichloropropan- 2-ol above the acceptable uptake level during continuous use (>30 days) in pediatric patients.
Dräger’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 in 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.
Potential Patient Impact
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, Dräger has not received any reported symptoms of an acute toxic reaction, nor any other complaints relating to this issue via our market surveillance.
Only the products listed below (all serial numbers) are included in the voluntary recall:
| Product Name | Part Number | UDI Number |
|---|---|---|
| Dräger Carina Sub-Acute Care Ventilator | 5704110 | 04048675398516 |
Required Action
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 Dräger leak valve is used; and
- an inline bacterial filter is used in accordance with the Instructions for Use.
This voluntary medical device recall has been reported to the U.S. Food and Drugs Administration (USFDA).
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