Smiths Medical Issues Recall for ParaPAC Plus Ventilators

Smiths Medical Issues Recall for ParaPAC Plus Ventilators

Smiths Medical Issues Recall for ParaPAC Plus Ventilators

This recall pertains to the withdrawal of specific devices from their usage or sales locations. The FDA categorizes this recall as the highest level of severity. Continuing to use this device could lead to serious injury or fatality.

Product in Question

PneuPAC paraPAC Plus Ventilator
  • Product Names: PneuPAC paraPAC Plus P300 and P310 Ventilators
  • Unique Device Identifier (UDI)/List Number: /P300NXX*, / P310NXX*
  • Model Numbers: All models are included in this recall.

Actions to Take

  • Check the patient outlet connector on all paraPAC plus ventilators.
  • If the outlet connector appears loose or movable, take the ventilator out of operation.

On May 31, 2024, Smiths Medical informed all impacted customers via an Urgent Medical Device Correction letter, advising them to:

  • Evaluate all potentially affected paraPAC plus devices:
    • Conduct a visual assessment to see if the outlet connector is disconnected.
    • Physically assess the connector to verify if it feels loose or shifts when attaching or detaching the patient circuit.
  • Remove any units where the outlet connector is found to be loose for correction by Smiths Medical.
  • Notify Global Complaint Management at globalcomplaints@icumed.com about any removed devices.
  • Continue using ventilators if the outlet connector remains secure after inspection, while maintaining high vigilance and adhering to all pre-use checks from the user manual.
  • Ensure that pre-checks are fulfilled as outlined in the user manual for every use following inspection:
    • Exercise extra caution to inspect the outlet connector before each use and during patient circuit changes.
  • Adhere strictly to the user manual instructions, including warnings and cautions for documents (10018833-003 and/or 10026347-002):
    • Conduct all pre-use checks before operation.
    • Maintain constant monitoring of the patient.
    • Utilize pulse oximetry and capnography for monitoring blood oxygen levels and carbon dioxide levels independently.
    • Have alternative ventilation strategies, such as bag-mask ventilation, readily available in cases of ventilator failure.
  • Be aware of potential design alerts triggered by this issue:
    • Low Pressure/Disconnect alarm
    • Pressure Monitor: The disconnection of the patient outlet connector would lead to a stationary manometer needle.
  • Distribute this recall information to all potential users to ensure awareness of the situation and the recommended actions.
  • Complete and return the customer response form from the letter to smithsmedical5253@sedgwick.com within 10 days of receiving it.
  • DISTRIBUTORS: Promptly send this notification to any customers who might have received these devices from you, requesting them to fill out and return the response form to smithsmedical5253@sedgwick.com.

Reason for the Recall

The motivation behind the recall of paraPAC plus P300 and P310 ventilators by Smiths Medical is the risk that the patient outlet connector could become loose or detach, adversely affecting ventilation. A loose or disconnected connector may lead to therapy interruptions, lack of ventilation, therapy delays, or diminished tidal volume.

Utilizing the affected devices could result in severe health problems, including inadequate ventilation (hypoventilation), insufficient oxygen (hypoxia), reduced heart rate (bradycardia), low blood pressure (hypotension), respiratory failure (arrest), or fatality.

There has been one reported injury and one death associated with this issue.

Device Utilization

Smiths Medical’s PneuPAC paraPAC Plus P300 and P310 Ventilators are gas-driven emergency and transport portable ventilators suitable for various settings, including aircraft and ambulances. They are particularly designed for emergency interventions at accident sites and patient transfers between hospitals or facilities. These ventilators offer ventilatory assistance for adults, children, and infants (above approximately 10 kg).

The paraPAC Plus units also facilitate free-flow oxygen therapy and CPAP therapy for spontaneously breathing patients. They can be critical during emergencies to deliver ventilatory support for CPR resuscitation.

Usage of paraPAC Plus ventilators should be conducted under the vigilant supervision of qualified healthcare personnel.

Contact Information

For inquiries regarding this recall, U.S. customers should reach out to Smiths Medical Technical Support at 1-800-241-4002, option 3.

Additional Resources from FDA

  • Ventilator Correction: Smiths Medical Issues Correction for paraPAC Plus P300 and P310 Ventilators due to Inadvertent Tidal Volume Knob Movement [9/11/2024]
  • FDA’s Enforcement Reports
  • Medical Device Recall Database

Unique Device Identifier (UDI)

The unique device identifier (UDI) serves to differentiate individual medical devices sold in the U.S., tracing them from production through to patient utilization. The UDI enhances the accuracy of reporting, examining, and interpreting adverse event reports, enabling quicker identification of devices and potential issues resolution.

Reporting Problems

Healthcare professionals and consumers are encouraged to report any adverse reactions or quality issues encountered with these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.