In conjunction with the FDA, Sentec/Percussionaire has announced a Class 1 correction to the usage instructions for the Phasitron 5 In-Line Valve, which is used for Intrapulmonary Percussive Ventilation (IPV). The company released the corrections after receiving six reports of injury from patients using recalled device.
The Sentec/Percussionaire Phasitron 5 In-Line Valve is a component of an IPV system that is used to clear the airways of patients receiving ventilation support. Sentec/Percussionaire issued the correction on September 3, 2004, linking it to 23 lots of the Phasitron 5 In-Line Valve, which has a UDI and Part Number of 00849436000723 and P5-TEE-20 (pack of 20)/ P5-Tee (individual). The lot numbers included in the urgent correction are as follows: 240620, 240610, 240418, 240326, 230612, WO07066, WO07010, WO06020, WO05019, WO04884, WO04827, WO04756, WO04714, WO04656, WO04625, WO04596, WO04553, WO04398, WO04356, WO04061, WO03846, WO03748, WO03688. The correction involves updated instructions and does not require the removal of these devices from use.
The instances of injury from use of the Phasitron 5 In-Line Valve occurred when users left the blue cap connected to the expiratory port on the ventilator while administering therapy. Failure to remove the blue cap during therapy can cause the ventilator to deliver too much pressure to the patient. This increased pressure can cause serious injuries that include “heart attack (cardiac arrest), air entering the space between the lung and the chest wall (pneumothorax), an airway (tracheobronchial) tear and death.”
The company’s Urgent Medical Device Correction letter emphasizes the need to remove the blue cap from the expiratory port on the ventilator when the machine is in active use. When the machine is not in active use, the blue cap can be used to prevent dust and other contaminants from entering the expiratory port. Sentec asks that health care facilities re-train all users of the Phasitron 5 In-Line Valve to ensure they understand the need to remove the blue cap from the expiratory port during active delivery of ventilation therapy to the patient. Facilities might consider posting the updated instructions and reminders in all areas where the device is used. Finally, facilities should label all P5-TEE bags with the stickers provided by Sentec/Percussionaire.
Anyone with questions about the updated instructions for use can contact customer service for Sentec/Percussionaire at FSCA@sentec.com.
Patients and health care providers can report any new adverse health events related to the Phasitron 5 In-Line Valve through the FDA’s MedWatch Online Voluntary Reporting Form.
If you or a loved one has suffered an adverse health outcome caused by the improper use of the Phasitron 5 In-Line Valve for IPV, we urge you to get in touch with our team. It’s vital that the liable parties be held accountable for their negligence to prevent further injury to patients receiving ventilation therapy. Our experienced attorneys at TruLaw are prepared to learn about your story and help you build a case for just compensation. Contact us today or try out our free Instant Case Evaluation ℠ to get started.