IPV Correction: Updates to In-Line Valve Instructions from Sentec/Percussionaire

IPV Correction: Updates to In-Line Valve Instructions from Sentec/Percussionaire

This recall consists of updating the usage instructions for these devices, and does not imply their withdrawal from sale or use locations. The FDA has categorized this recall as the most critical type. Continuing to use this device without adhering to the revised instructions could lead to serious injury or death.

Product Overview

Product Name: Phasitron 5 In-Line Valve

Unique Device Identifier (UDI) and Part Number: 00849436000723, P5-TEE-20 (pack of 20)/ P5-Tee (individual)

Potentially Affected Lots #: 240620, 240610, 240418, 240326, 230612, WO07066, WO07010, WO06020, WO05019, WO04884, WO04827, WO04756, WO04714, WO04656, WO04625, WO04596, WO04553, WO04398, WO04356, WO04061, WO03846, WO03748, WO03688

Steps to Take

  • Adhere to the updated usage guidelines and labeling.
  • Take off the cap on the expiratory port when delivering therapy directly through the mouth, mask, or while connected to an endotracheal or tracheostomy tube.

On September 3, 2024, Sentec/Percussionaire issued an Urgent Medical Device Correction letter to affected customers advising the following:

  • Examine the updated instructions for correct in-line use along with the updated instructions for use (IFU), which include: 
    • The blue cap that comes with the P5-TEE is strictly for protective purposes only. This cap is to be used on the in-line valve (P5-TEE) Phasitron 5 port connection when therapy is not being administered, preventing any particles from entering the valve.
    • The Phasitron 5 expiratory port must remain clear and unobstructed during treatment.

IMPORTANT: The revised instructions differ from the previous IFU (P20020 Rev E).

  • Adjust institutional protocols and practices regarding the use of the P5-TEE as needed per the updated guidance and labeling.
  • Print and display the updated instructions for In-Line Valve usage throughout the facility.
  • Instruct and train primary users of IPV therapy on the updated instructions for correct usage.
  • Re-label existing products by affixing the stickers from Percussionaire on each P5-TEE bag in stock (stickers will be dispatched via mail).
  • Complete and return the acknowledgment form included with the letter by September 27, 2024.

Rationale for Use Instruction Updates

The updates to the Phasitron 5 In-Line Valve usage instructions are due to a rise in reports of patient injuries attributed to users neglecting to remove the blue plug from the expiratory port while delivering therapy directly to a patient’s airway. This oversight can cause excessive pressure from the ventilator to the patient.

Utilizing the affected product without following the updated instructions could result in serious health complications, including cardiac arrest, pneumothorax (air accumulation between lung and chest wall), tracheobronchial tears, and even death.

As of now, six injuries have been reported, and there have been no recorded fatalities.

Device Application

The Intrapulmonary Percussive Ventilation (IPV) Phasitron 5 In-Line Valve is part of the Phasitron 5 system, which delivers IPV therapy to patients on mechanical ventilation, facilitating better breathing. This therapy aids in enhancing gas exchange and maintaining airway patency during ventilation.

Contact Information

U.S. customers with inquiries regarding this recall should reach out to Sentec/Percussionaire customer service at FSCA@sentec.com.

Further FDA Resources

  • FDA’s Enforcement Reports
  • Medical Device Recall Database Entries

Unique Device Identifier (UDI)

The unique device identifier (UDI) is crucial for pinpointing individual medical devices in the United States, tracking them from manufacturing through distribution to patient application. This identification facilitates more precise reporting and analysis of adverse events, allowing for potential issues to be addressed more swiftly.

How to Report a Problem?

Health care professionals and consumers can report adverse reactions or quality issues with these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.