FDA announces Smiths Medical ventilator recall

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The FDA's Center for Veterinary Medicine (CVM) announced Smiths Medical’s recall of the PneuPAC paraPAC Plus P300 and PneuPAC paraPAC Plus P310 ventilator models (all models affected) due to the possibility that the patient outlet connector may loosen or come detached, which would impact active ventilation.^1,2 Ventilation therapy could be interrupted, delayed, or even prevented by the loosening or detachment of the patient outlet connector. The FDA identified the recall as Class I, the most serious classification, with the potential to cause injury or death with continued use.³ The recall follows 1 reported injury, and 1 reported death associated with the device.

The FDA listed the official reason for the recall of both models as: “a potential for inadvertent tidally volume knob movement from the original setting when set at high (1000-1500 mL) and low (70-150 mL) settings.”²

Veterinary practices affected by the recall are encouraged to inspect the patient outlet connector on all paraPAC plus ventilators, removing units from use if the outlet connector is loose or moves. The recall involves the removal of all devices from where they are used or sold.³ Smiths Medical and the FDA warn that continued use of the product may cause serious health consequences, including:^1,2

• Hypoventilation
• Hypoxia
• Bradycardia
• Hypotension
• Respiratory arrest
• Death

Smiths Medical PneuPAC paraPAC Plus P300 and PneuPAC paraPAC Plus P310 ventilators are gas-powered emergency ventilators designed with portability in mind, initially for use in vehicles like airplanes and helicopters. The ventilators are typically used during transportation between hospitals or within facilities. The paraPAC Plus devices provide free flow oxygen therapy and continuous positive airway pressure (CPAP) therapy for spontaneously breathing patients, and can also be used in emergency situations as ventilatory support for CPR resuscitation.²

On May 31, 2024, Smiths Medical sent Urgent Device Correction letters to all affected customers, urging them to perform visual and physical inspections, removing affected units from use and reporting them to Global Complaint Management for Smiths Medical repairs, while continuing to use devices that passed inspections. The letters also reminded users about warnings and cautions mentioned in the user manual. The manual recommended pre-checks prior to each use, constant patient monitoring, monitoring blood oxygenation and end tidal carbon dioxide levels independently with pulse oximetry and capnography, and ensuring alternate means of ventilation, in case of ventilator failure or malfunction. They also shared the potential for the low pressure/disconnect and pressure monitor alarms to be triggered by the issue.²

References

1. Recall of Certain Ventilators Potentially Used in Veterinary Settings. US Food and Drug Administration. September 23, 2024. Accessed September 23, 2024.
2. Ventilator Recall: Smiths Medical Removes ParaPAC Plus Ventilators due to Loosened or Detached Patient Outlet Connector. US Food and Drug Administration. Accessed September 23, 2024. https://www.fda.gov/medical-devices/medical-device-recalls/ventilator-recall-smiths-medical-removes-parapac-plus-ventilators-due-loosened-or-detached-patient?utm_medium=email&utm_source=govdelivery
3. What is a Medical Device Recall? US Food and Drug Administration. Accessed September 23, 2024. https://www.fda.gov/medical-devices/medical-device-recalls/what-medical-device-recall