Sentec/Percussionaire has updated use instructions for Phasitron 5 In-Line Valve to prevent accidental misuse of expiratory port plug.

RT’s Three Key Takeaways:

  1. Sentec is updating instructions for its IPV Phasitron 5 In-Line Valve due to patient injuries caused by failure to remove a blue plug during direct airway therapy.
  2. Improper use of the device can lead to serious health consequences, including cardiac arrest, pneumothorax, and tracheobronchial tear, with six reported injuries so far.
  3. The FDA has classified this as a Class I recall, its most serious type, and Sentec has issued specific actions for healthcare providers to take, including reviewing updated instructions and retraining staff.

Sentec/Percussionaire is updating use instructions for the intrapulmonary percussive ventilation (IPV) Phasitron 5 In-Line Valve due to an increase in reports of patient injuries after users failed to remove the blue plug from the expiratory port when applying therapy directly to a patient’s airway. 

Failure to remove this cap during direct airway therapy can lead to the patient receiving too much pressure from the ventilator. The use of affected product without following updated instructions may cause serious adverse health consequences, including cardiac arrest, pneumothorax, tracheobronchial tear, and death.

There have been six reported injuries. There have been no reports of death. The US Food and Drug Administration (FDA) has identified this as a Class I recall, the most serious type.

The Phasitron 5 In-Line Valve is part of the Phasitron 5 system that provides IPV therapy to patients who are receiving mechanical ventilation to help them breathe. This type of therapy can improve gas exchange and help keep the airways clear during ventilation.

Affected product:

  • Product name: Phasitron 5 In-Line Valve
  • Unique device identifier (UDI) and part number: 00849436000723, P5-TEE-20 (pack of 20)/P5-Tee (individual)
  • Potential lots affected: 240620, 240610, 240418, 240326, 230612, WO07066, WO07010, WO06020, WO05019, WO04884, WO04827, WO04756, WO04714, WO04656, WO04625, WO04596, WO04553, WO04398, WO04356, WO04061, WO03846, WO03748, WO03688

What to Do

On Sept 3, Sentec/Percussionaire sent all affected customers an Urgent Medical Device Correction letter recommending the following actions:

  • Review updated instructions for proper in-line use and updated instructions for use (IFU) as follows:
    • The blue cap provided with the P5-TEE is to be used as a protective cap ONLY. The protective cap is only to be placed on the in-line valve (P5-TEE) Phasitron 5 port connection when therapy is not being provided to prevent any particles from entering the valve.
    • The Phasitron 5 expiratory port should remain open and unobstructed when giving treatment.
    • Note: These updated instructions differ from the prior IFU (P20020 Rev E).
  • Revise institutional protocols and procedures related to use of the P5-TEE as necessary based on the updated instructions and labeling.
  • Print and post updated instructions for proper In-Line Valve use throughout the facility.
  • Communicate and train primary users of IPV therapy using the updated instructions for proper use.
  • Re-label current product by placing the sticker provided by Percussionaire on each individual P5-TEE bag on stock (stickers provided via mail).
  • Complete and return acknowledgement form included with the letter by September 27, 2024.

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.

Percussionaire was acquired by Sentec in September 2022.