Hamilton Medical issued a recall for certain coaxial breathing circuit sets used with C1, T-1, and MR1 ventilators, ordering them removed from where they are used or sold, according to an FDA alert.
The coaxial breathing circuits are intended to connect Hamilton-C1/T1/MR1 ventilators to a patient tube or respiratory mask during ventilation.
The FDA reports 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 FDA says. 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, according to the FDA.
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, according to the FDA.
Affected devices:
| Product Name | Brand Name | Product Number | UDI-DI |
|---|---|---|---|
| T1 CIRCUIT 240 +VALVE B/10 | Hamilton Breathing circuit sets, coaxial | 260127 | 07630002802956 |
| T1 CIRCUIT 180 +VALVE B/20 | Hamilton Breathing circuit sets, coaxial | 260128 | 07630002802963 |
| MR1 CIRCUIT 300 +VALVE B/10 | Hamilton Breathing circuit sets, coaxial | 260167 | 07630002802970 |
| MR1 CIRCUIT 480 +VALVE B/8 | Hamilton Breathing circuit sets, coaxial | 260168 | 07630002802987 |
FDA Recommendations
According to the FDA alert, do not use affected coaxial breathing circuit sets. Check your stock for affected item and lot numbers.
The FDA reports that Hamilton Medical issued a letter on May 22, to provide recommendations for affected customers. On July 01, Hamilton Medical issued a follow-up letter to provide updated guidance regarding breathing circuit use. Hamilton Medical recommends affected users take the following actions:
- Immediately check your stock for the affected item and lot numbers. Quarantine all affected product for return to Hamilton Medical for replacement.
- Inform all potential users of affected coaxial breathing circuit sets about this issue and post the provided notice in your facility. Make sure recommended actions are followed.
More information is available on the FDA website.
