Smiths Medical has issued a recall of PneuPAC paraPAC Plus P300 and P310 ventilators due to a faulty patient outlet connector that can loosen or detach.

RT’s Three Key Takeaways:

  1. Smiths Medical is recalling PneuPAC paraPAC Plus P300 and P310 ventilators due to the risk of the patient outlet connector loosening or detaching, which could interrupt ventilation.
  2. The FDA has classified this as a Class I recall, the most serious type, warning of potential life-threatening health consequences, including hypoxia and respiratory arrest.
  3. Affected healthcare providers are urged to inspect all devices immediately, with any loose connectors requiring removal for repair to avoid potential failures during patient use.

Smiths Medical is recalling paraPAC plus P300 and P310 ventilators due to the possibility that the patient outlet connector may loosen or detach, which will impact active ventilation. 

If the patient outlet connector is loosened or detached it could cause extended interruption of therapy, no ventilation, delay of therapy, and reduced tidal volume.

The use of the affected product may cause serious adverse health consequences, including hypoventilation, hypoxia, bradycardia, hypotension, respiratory arrest, and death. The US Food and Drug Administration has identified this recall as the most serious type. There has been one reported injury and one report of death.

[RELATED: Smiths Medical Recalls PneuPac paraPAC Plus Ventilator Kits]

Smiths Medical PneuPAC paraPAC Plus P300 and P310 ventilators are gas-powered emergency and transport portable ventilators, including in vehicles such as airplanes and helicopters. They are suitable for emergency use at accident scenes and transports between hospitals or within a hospital or medical facility. These ventilators are intended to provide ventilatory support for adults, children, and infants.

The paraPAC Plus devices also provide free-flow oxygen therapy and continuous positive airway pressure therapy for spontaneously breathing patients. The devices can also be used in emergency situations to provide ventilatory support for CPR resuscitation.

ParaPAC Plus ventilators should only be used under the constant supervision of trained health care professionals.

This recall involves removing certain devices from where they are used or sold. 

Affected product:

  • Product names: PneuPAC paraPAC Plus P300 and P310 Ventilators
  • Unique device identifier (UDI)/List Number: /P300NXX*, / P310NXX*
  • Model numbers: All models are affected.

What to Do

On May 31, Smiths Medical sent all affected customers an Urgent Medical Device Correction letter recommending the following actions:

  • Inspect all potentially affected paraPAC plus units to determine if devices are affected:
    • Perform a visual inspection to determine if the outlet connector is disconnected.
    • Evaluate the connector physically to determine if the outlet connector is loose or moves when placing a patient circuit on the connector or when removing it.
  • Remove any device where the outlet connector moves or feels loose so it can be repaired by Smiths Medical.
  • Report removed devices to Global Complaint Management at [email protected].
  • Continue to use devices if the outlet connector remains tight after physical inspection, maintaining heightened awareness and following all pre-use checks as per the user manual.
  • Pre-checks must be completed as described in the user manual for every use after inspection.
    • Take extra caution to inspect the outlet connector prior to each use, before placing the patient circuit on the connector, and during removal.
  • Be sure to follow all instructions including warnings and cautions in the UserManual Doc. numbers (10018833-003 and/or 10026347-002) when using these devices, including:
    • All pre-use checks must be performed before each use.
    • Constant patient monitoring.
    • Monitor blood oxygenation and end tidal carbon dioxide levels independently with pulse oximetry and capnography.
    • Have alternate means of ventilation, such as bag mask ventilation, available in case of ventilator failure or malfunction.
  • The following design mitigation and alarms may be triggered by this issue:
    • Low Pressure/Disconnect alarm
    • Pressure Monitor: Disconnection/detachment of the patient outlet connector would be indicated by no movement of the manometer needle.
  • Share this recall notification with all potential users of the devices to ensure they are aware of the issue and proposed mitigations.
  • Complete and return the customer response form included with the letter to [email protected] within 10 days of receipt.
  • Distributors: Immediately forward this notice to any customer who may have received these devices from you. Request that they complete the response form and return it to [email protected].