CareFusion AVEA Ventilator Recalled for Pressure Transducer Failure
CareFusion is recalling AVEA ventilators because a pressure transducer failure can stop ventilation. Nonbreathing patients may require manual ventilation or a different device.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "A pressure transducer failure can develop, activating a false Extended High Ppeak or Circuit Occlusion Alarm. The Safety Valve will open to ambient air and the unit will stop ventilating, allowing spontaneous breathing patients to breathe.…"
Plain-English summary
CareFusion 211 Inc dba CareFusion is recalling CareFusion AVEA ventilators, all models. The recall involves 15,905 units total, with 5,670 units distributed in the US. The devices are distributed worldwide, including in the US, Canada, and numerous other countries.
The recall is due to a potential pressure transducer failure that can activate a false Extended High Ppeak or Circuit Occlusion Alarm. When this occurs, the Safety Valve opens to ambient air and the unit stops ventilating. While spontaneous breathing patients can continue to breathe, the malfunction may delay the initiation of ventilation or cease it entirely. Nonbreathing patients will need manual ventilation or to be connected to another ventilator.
Healthcare facilities and users should check their serial numbers against the list provided in the official recall notice. If a device is affected, it should be removed from service and replaced or repaired according to the manufacturer's instructions.
The recalled product
- Product
- CareFusion AVEA ventilator, all models. Product Usage: A continuous ventilator (respirator), intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.
- Manufacturer
- Carefusion 211 Inc dba Carefusion
- Category
- Medical Device — Ventilator
Distribution
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