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Breathing Circuit Set Recall: Hamilton Medical Removes Breathing Circuit Set
The FDA is aware that Hamilton Medical has issued a letter to affected customers recommending certain coaxial breathing circuit sets used with HAMILTON-C1, HAMILTON T-1, and HAMILTON-MR1 ventilators be removed from where they are used or sold.
Hamilton Medical stated that certain lots of coaxial breathing circuit sets preassembled with an expiratory valve set do not perform as intended. In some cases, the expiratory valve membrane adhered to the sealing ring on the body of the expiratory valve, impairing valve opening and expiratory gas flow. The issue is not detected during the pre-operative test of the ventilator unless a test lung is actively ventilated. If the expiratory valve membrane is adhered to the sealing ring, the malfunction appears within the first breaths after ventilation is initiated.
When the expiratory gas flow is impeded, the end-expiratory pressure is too high, or the end-expiratory flow is too low. This will trigger the ventilator’s “Exhalation Obstructed” alarm.
An obstruction of expiratory flow results in inadequate ventilation and impaired gas exchange. Acute respiratory compromise due to impaired exhalation may result in inadequate ventilation and oxygen desaturation (hypoxemia).
As of July 2, Hamilton Medical has reported four serious injuries and no deaths associated with this issue.
Questions?
Customers in the U.S. with adverse reactions, quality problems, or questions about this issue should contact Hamilton Medical at complaints@hamiltonmedical.com or (800)-426-6331.
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